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LABELS · a284d45e-6142-4bfa-b716-7f2b976ffb0b

Truxima

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-07-13
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue TRUXIMA infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [ see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [ see Warnings and Precautions (5.2) ]. Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation [ see Warnings and Precautions (5.3) ]. Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [ see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ].

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ) 1.1 Non–Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) TRUXIMA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) TRUXIMA, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) TRUXIMA is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
Full extracted label fields
application numbers
  1. BLA761088
boxed warning exact
  1. WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue TRUXIMA infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [ see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [ see Warnings and Precautions (5.2) ]. Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation [ see Warnings and Precautions (5.3) ]. Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [ see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ].
brand names
  1. Truxima
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9af3ddc7-4217-417a-ac89-8704edc5bc44
generic names
  1. RITUXIMAB-ABBS
id
a284d45e-6142-4bfa-b716-7f2b976ffb0b
indications and usage exact
  1. 1 INDICATIONS AND USAGE TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens. Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ) 1.1 Non–Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) TRUXIMA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) TRUXIMA, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). 1.5 Pemphigus Vulgaris (PV) TRUXIMA is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Cephalon, Inc.
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    1. lymphoma
    2. leukemia
    package ndcs
    1. 63459-103-10
    2. 63459-104-50
    product ndcs
    1. 63459-103
    2. 63459-104
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. RECENT MAJOR CHANGES Indications and Usage, Pemphigus Vulgaris (1.5) 06/2025 Dosage and Administration (2.7, 2.8) 06/2025 Warnings and Precautions (5.1, 5.12) 06/2025
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    1. INTRAVENOUS
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    1. 2105826
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    meta
    disclaimer
    Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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    source url
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    spl effective date
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    spl effective time
    20260713
    spl set id
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    spl version
    16
    substance names
    1. RITUXIMAB
    uniis
    1. 4F4X42SYQ6
    verification flags
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    3. individual_indications_not_split_or_reconciled
    Drugs@FDA application source records
    1. application number
      BLA761088
      payload
      all indexed label documents
      1. Appl No
        761088
        Application Docs Date
        2018-11-28 00:00:00
        Application Docs ID
        56580
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761088
        Application Docs Date
        2019-05-31 00:00:00
        Application Docs ID
        58846
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        2
        Submission Type
        SUPPL
      3. Appl No
        761088
        Application Docs Date
        2019-05-31 00:00:00
        Application Docs ID
        58847
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      4. Appl No
        761088
        Application Docs Date
        2019-12-19 00:00:00
        Application Docs ID
        61354
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
        SUPPL
      5. Appl No
        761088
        Application Docs Date
        2019-12-19 00:00:00
        Application Docs ID
        61355
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        6
        Submission Type
        SUPPL
      6. Appl No
        761088
        Application Docs Date
        2020-06-02 00:00:00
        Application Docs ID
        63393
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      7. Appl No
        761088
        Application Docs Date
        2022-02-08 00:00:00
        Application Docs ID
        70121
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        18
        Submission Type
        SUPPL
      8. Appl No
        761088
        Application Docs Date
        2025-08-29 00:00:00
        Application Docs ID
        83235
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        32
        Submission Type
        SUPPL
      9. Appl No
        761088
        Application Docs Date
        2026-07-06 00:00:00
        Application Docs ID
        86466
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        35
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        15
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2018-11-28 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2019-05-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2019-05-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2019-12-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2019-12-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2020-05-29 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        761088
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        18
        Submission Status
        AP
        Submission Status Date
        2022-02-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        761088
        Review Priority
        Submission Class Code ID
        28
        Submission No
        32
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        Submission Status Date
        2025-06-09 00:00:00
        Submission Type
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        Submissions Public Notes
      9. Appl No
        761088
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        N/A
        Submission Class Code ID
        1
        Submission No
        35
        Submission Status
        AP
        Submission Status Date
        2026-06-29 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
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      true
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      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        761088
        Application Docs Date
        2026-07-06 00:00:00
        Application Docs ID
        86466
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
        35
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      official application record
      Appl No
      761088
      Appl Public Notes
      Appl Type
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      Sponsor Name
      CELLTRION INC
      openfda application present
      true
      products
      1. Active Ingredient
        RITUXIMAB-ABBS
        Appl No
        761088
        Drug Name
        TRUXIMA
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        100MG/10ML(10MG/ML)
        marketing status
        1. Prescription
      2. Active Ingredient
        RITUXIMAB-ABBS
        Appl No
        761088
        Drug Name
        TRUXIMA
        Form
        INJECTABLE;INJECTION
        Product No
        002
        Reference Drug
        0
        Reference Standard
        0
        Strength
        500MG/50ML(10MG/ML)
        marketing status
        1. Prescription

    Source passages and status connections

    Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

    Passage 1 · positive indication candidate
    application numbers
    1. BLA761088
    brand names
    1. Truxima
    classification reasons
    1. explicit_positive_indication_predicate
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    clinical review status
    pending
    content role
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    1 INDICATIONS AND USAGE TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
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    qualifier mentions
    1. context exact
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    2. context exact
      1 INDICATIONS AND USAGE TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymph
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        1 INDICATIONS AND USAGE TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ).
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                                  Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
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                                  application numbers
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                                  cline-based chemotherapy regimens. Chronic Lymphocytic Leukemia (CLL) ( 1.2 ). Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC). Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ). Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgar
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                                    in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1
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                                      1265
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                                      Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies ( 1.3 ).
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                                      source url
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                                      Source null
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                                      Source null
                                      use intent
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                                      Passage 9 · unclassified context
                                      application numbers
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                                      brand names
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                                      1629
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                                          1429
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                                          Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ).
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                                          source url
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                                          line
                                          Source null
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                                          tumor histology
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                                          Passage 10 · unclassified context
                                          application numbers
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                                              Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 )
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                                              Passage 11 · positive indication candidate
                                              application numbers
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                                              1905
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                                              (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids ( 1.4 ). Moderate to severe Pemphigus Vulgaris (PV) in adult patients ( 1.5 ) 1.1 Non–Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination
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                                              1. context exact
                                                TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20
                                                kind
                                                age
                                                polarity
                                                not_inferred
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                                                end exclusive
                                                true
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                                                adult patients
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                                                start
                                                1591
                                              2. context exact
                                                ents with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
                                                kind
                                                biomarker
                                                polarity
                                                not_inferred
                                                span
                                                end
                                                1674
                                                end exclusive
                                                true
                                                exact text
                                                CD20-positive
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                                                unicode_code_points
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                                                start
                                                1661
                                              3. context exact
                                                bbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a si
                                                kind
                                                stage_or_setting
                                                polarity
                                                not_inferred
                                                span
                                                end
                                                1634
                                                end exclusive
                                                true
                                                exact text
                                                Relapsed or refractory
                                                label id
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                                                start
                                                1612
                                              4. context exact
                                                ractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
                                                kind
                                                regimen
                                                polarity
                                                not_inferred
                                                span
                                                end
                                                1704
                                                end exclusive
                                                true
                                                exact text
                                                as a single agent
                                                label id
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                                                start
                                                1687
                                              regulatory links
                                                schema version
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                                                source batch sha256
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                                                source defined aliases
                                                  source span
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                                                  1705
                                                  end exclusive
                                                  true
                                                  exact text
                                                  1.1 Non–Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.
                                                  label id
                                                  a284d45e-6142-4bfa-b716-7f2b976ffb0b
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                                                  start
                                                  1499
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%22a284d45e-6142-4bfa-b716-7f2b976ffb0b%22
                                                  spl effective date
                                                  2026-07-13
                                                  spl set id
                                                  9af3ddc7-4217-417a-ac89-8704edc5bc44
                                                  spl version
                                                  16
                                                  structured fields status
                                                  not_extracted_no_values_inferred_from_mentions
                                                  structured indication
                                                  age
                                                  Source null
                                                  approval pathway
                                                  Source null
                                                  biomarker and test
                                                  Source null
                                                  disease stage
                                                  Source null
                                                  limitations
                                                  Source null
                                                  line
                                                  Source null
                                                  prior therapy
                                                  Source null
                                                  regimen
                                                  Source null
                                                  tumor histology
                                                  Source null
                                                  use intent
                                                  tumor_directed_candidate
                                                  Passage 12 · positive indication candidate
                                                  application numbers
                                                  1. BLA761088
                                                  brand names
                                                  1. Truxima
                                                  classification reasons
                                                  1. inherited_predicate_from_same_label_section_requires_review
                                                  2. no_tumor_directed_keyword_in_positive_statement
                                                  clinical review status
                                                  pending
                                                  content role
                                                  positive_indication_candidate
                                                  context span
                                                  end
                                                  2160
                                                  end exclusive
                                                  true
                                                  exact text
                                                  –Hodgkin's Lymphoma (NHL) TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untrea
                                                  label id
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                                                  offset unit
                                                  unicode_code_points
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                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
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                                                  start
                                                  1506
                                                  current approval status
                                                  not_reconciled
                                                  duplicate text group
                                                  dup-54fb42155e79818c22ca
                                                  extraction review status
                                                  automated_candidate_pending_source_review
                                                  generic names
                                                  1. RITUXIMAB-ABBS
                                                  id
                                                  ind-span-4f4fb74f4746f9fa0a01
                                                  label id
                                                  a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                  positive predicate support span
                                                  end
                                                  1569
                                                  end exclusive
                                                  true
                                                  exact text
                                                  is indicated
                                                  label id
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                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
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                                                  start
                                                  1557
                                                  qualifier mentions
                                                  1. context exact
                                                    Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and
                                                    kind
                                                    biomarker
                                                    polarity
                                                    not_inferred
                                                    span
                                                    end
                                                    1752
                                                    end exclusive
                                                    true
                                                    exact text
                                                    CD20-positive
                                                    label id
                                                    a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
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                                                    source text sha256
                                                    1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                    start
                                                    1739
                                                  2. context exact
                                                    Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent mainte
                                                    kind
                                                    prior_therapy_or_line
                                                    polarity
                                                    not_inferred
                                                    span
                                                    end
                                                    1886
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab prod
                                                    label id
                                                    a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                    start
                                                    1706
                                                  3. context exact
                                                    Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                                                    kind
                                                    regimen
                                                    polarity
                                                    not_inferred
                                                    span
                                                    end
                                                    1944
                                                    end exclusive
                                                    true
                                                    exact text
                                                    in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent main
                                                    label id
                                                    a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
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                                                    start
                                                    1765
                                                  regulatory links
                                                    schema version
                                                    0.1.0
                                                    source batch sha256
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                                                    source defined aliases
                                                      source span
                                                      end
                                                      1960
                                                      end exclusive
                                                      true
                                                      exact text
                                                      Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
                                                      label id
                                                      a284d45e-6142-4bfa-b716-7f2b976ffb0b
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                                                      unicode_code_points
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                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
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                                                      start
                                                      1706
                                                      source url
                                                      https://api.fda.gov/drug/label.json?search=id%3A%22a284d45e-6142-4bfa-b716-7f2b976ffb0b%22
                                                      spl effective date
                                                      2026-07-13
                                                      spl set id
                                                      9af3ddc7-4217-417a-ac89-8704edc5bc44
                                                      spl version
                                                      16
                                                      structured fields status
                                                      not_extracted_no_values_inferred_from_mentions
                                                      structured indication
                                                      age
                                                      Source null
                                                      approval pathway
                                                      Source null
                                                      biomarker and test
                                                      Source null
                                                      disease stage
                                                      Source null
                                                      limitations
                                                      Source null
                                                      line
                                                      Source null
                                                      prior therapy
                                                      Source null
                                                      regimen
                                                      Source null
                                                      tumor histology
                                                      Source null
                                                      use intent
                                                      non_oncology_or_unclear_candidate
                                                      Passage 13 · unclassified context
                                                      application numbers
                                                      1. BLA761088
                                                      brand names
                                                      1. Truxima
                                                      classification reasons
                                                      1. no_unambiguous_positive_indication_predicate
                                                      clinical review status
                                                      pending
                                                      content role
                                                      unclassified_context
                                                      context span
                                                      end
                                                      2342
                                                      end exclusive
                                                      true
                                                      exact text
                                                      NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2
                                                      label id
                                                      a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                      start
                                                      1761
                                                      current approval status
                                                      not_reconciled
                                                      duplicate text group
                                                      dup-8e8a7542e1aa5852dc31
                                                      extraction review status
                                                      automated_candidate_pending_source_review
                                                      generic names
                                                      1. RITUXIMAB-ABBS
                                                      id
                                                      ind-span-7b2252a313a5ea11733c
                                                      label id
                                                      a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                      positive predicate support span
                                                      Source null
                                                      qualifier mentions
                                                      1. context exact
                                                        Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophospha
                                                        kind
                                                        biomarker
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2029
                                                        end exclusive
                                                        true
                                                        exact text
                                                        CD20-positive
                                                        label id
                                                        a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
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                                                        source text sha256
                                                        1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                        start
                                                        2016
                                                      2. context exact
                                                        ow-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                                        kind
                                                        prior_therapy_or_line
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2141
                                                        end exclusive
                                                        true
                                                        exact text
                                                        first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                                                        label id
                                                        a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                        start
                                                        2066
                                                      3. context exact
                                                        uding stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                                        kind
                                                        regimen
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2141
                                                        end exclusive
                                                        true
                                                        exact text
                                                        as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
                                                        label id
                                                        a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                        start
                                                        2042
                                                      regulatory links
                                                        schema version
                                                        0.1.0
                                                        source batch sha256
                                                        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                                        source defined aliases
                                                          source span
                                                          end
                                                          2142
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
                                                          label id
                                                          a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                          start
                                                          1961
                                                          source url
                                                          https://api.fda.gov/drug/label.json?search=id%3A%22a284d45e-6142-4bfa-b716-7f2b976ffb0b%22
                                                          spl effective date
                                                          2026-07-13
                                                          spl set id
                                                          9af3ddc7-4217-417a-ac89-8704edc5bc44
                                                          spl version
                                                          16
                                                          structured fields status
                                                          not_extracted_no_values_inferred_from_mentions
                                                          structured indication
                                                          age
                                                          Source null
                                                          approval pathway
                                                          Source null
                                                          biomarker and test
                                                          Source null
                                                          disease stage
                                                          Source null
                                                          limitations
                                                          Source null
                                                          line
                                                          Source null
                                                          prior therapy
                                                          Source null
                                                          regimen
                                                          Source null
                                                          tumor histology
                                                          Source null
                                                          use intent
                                                          unclear
                                                          Passage 14 · positive indication candidate
                                                          application numbers
                                                          1. BLA761088
                                                          brand names
                                                          1. Truxima
                                                          classification reasons
                                                          1. inherited_predicate_from_same_label_section_requires_review
                                                          2. no_tumor_directed_keyword_in_positive_statement
                                                          clinical review status
                                                          pending
                                                          content role
                                                          positive_indication_candidate
                                                          context span
                                                          end
                                                          2537
                                                          end exclusive
                                                          true
                                                          exact text
                                                          ntenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously tr
                                                          label id
                                                          a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                          start
                                                          1943
                                                          current approval status
                                                          not_reconciled
                                                          duplicate text group
                                                          dup-57b1c3b24a280c3257c0
                                                          extraction review status
                                                          automated_candidate_pending_source_review
                                                          generic names
                                                          1. RITUXIMAB-ABBS
                                                          id
                                                          ind-span-be45ebf157eb8140c2ab
                                                          label id
                                                          a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                          positive predicate support span
                                                          end
                                                          1569
                                                          end exclusive
                                                          true
                                                          exact text
                                                          is indicated
                                                          label id
                                                          a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                          start
                                                          1557
                                                          qualifier mentions
                                                          1. context exact
                                                            Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or o
                                                            kind
                                                            biomarker
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            2230
                                                            end exclusive
                                                            true
                                                            exact text
                                                            CD20-positive NHL in combination with cyclop
                                                            label id
                                                            a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                            start
                                                            2186
                                                          2. context exact
                                                            Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                                            kind
                                                            prior_therapy_or_line
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            2323
                                                            end exclusive
                                                            true
                                                            exact text
                                                            Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemothe
                                                            label id
                                                            a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                            start
                                                            2143
                                                          3. context exact
                                                            reviously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                                            kind
                                                            regimen
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            2336
                                                            end exclusive
                                                            true
                                                            exact text
                                                            in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
                                                            label id
                                                            a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                            start
                                                            2204
                                                          regulatory links
                                                            schema version
                                                            0.1.0
                                                            source batch sha256
                                                            424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                                            source defined aliases
                                                              source span
                                                              end
                                                              2337
                                                              end exclusive
                                                              true
                                                              exact text
                                                              Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
                                                              label id
                                                              a284d45e-6142-4bfa-b716-7f2b976ffb0b
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                                                              apy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. 1.2 Chronic Lymphocytic Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) TRUXIMA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inade
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                                                                .2 Chronic Lymphocytic Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
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                                                                in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL
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                                                                  1.2 Chronic Lymphocytic Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
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                                                                  Leukemia (CLL) TRUXIMA is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL. 1.3 Rheumatoid Arthritis (RA) TRUXIMA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. 1.4 Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) TRUXIMA, in combination with glucocorticoids, is indicated for the treatment of adult patients
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                                                                      1.3 Rheumatoid Arthritis (RA) TRUXIMA, in combination with methotrexate, is indicated for the treatment of adult patients with moderately-to-severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
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                                                                          1.4 Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) TRUXIMA, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA).
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                                                                          automated_candidate_pending_source_review
                                                                          generic names
                                                                          1. RITUXIMAB-ABBS
                                                                          id
                                                                          ind-span-3384e60d94469a139223
                                                                          label id
                                                                          a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                                          positive predicate support span
                                                                          end
                                                                          3172
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          is indicated
                                                                          label id
                                                                          a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                                          start
                                                                          3160
                                                                          qualifier mentions
                                                                          1. context exact
                                                                            gus Vulgaris (PV) TRUXIMA is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
                                                                            kind
                                                                            age
                                                                            polarity
                                                                            not_inferred
                                                                            span
                                                                            end
                                                                            3208
                                                                            end exclusive
                                                                            true
                                                                            exact text
                                                                            adult patients
                                                                            label id
                                                                            a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                                            offset unit
                                                                            unicode_code_points
                                                                            source array index
                                                                            0
                                                                            source field
                                                                            indications_and_usage_exact
                                                                            source text sha256
                                                                            1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                                            start
                                                                            3194
                                                                          regulatory links
                                                                            schema version
                                                                            0.1.0
                                                                            source batch sha256
                                                                            424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
                                                                            source defined aliases
                                                                              source span
                                                                              end
                                                                              3252
                                                                              end exclusive
                                                                              true
                                                                              exact text
                                                                              1.5 Pemphigus Vulgaris (PV) TRUXIMA is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris.
                                                                              label id
                                                                              a284d45e-6142-4bfa-b716-7f2b976ffb0b
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              1b3e667750f35b8aa478990053523d9869598a196428b8a02afb51815f8f0cad
                                                                              start
                                                                              3124
                                                                              source url
                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22a284d45e-6142-4bfa-b716-7f2b976ffb0b%22
                                                                              spl effective date
                                                                              2026-07-13
                                                                              spl set id
                                                                              9af3ddc7-4217-417a-ac89-8704edc5bc44
                                                                              spl version
                                                                              16
                                                                              structured fields status
                                                                              not_extracted_no_values_inferred_from_mentions
                                                                              structured indication
                                                                              age
                                                                              Source null
                                                                              approval pathway
                                                                              Source null
                                                                              biomarker and test
                                                                              Source null
                                                                              disease stage
                                                                              Source null
                                                                              limitations
                                                                              Source null
                                                                              line
                                                                              Source null
                                                                              prior therapy
                                                                              Source null
                                                                              regimen
                                                                              Source null
                                                                              tumor histology
                                                                              Source null
                                                                              use intent
                                                                              non_oncology_or_unclear_candidate

                                                                              Preserved source evidence · Not medical advice