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LABELS · ae54abc4-e9c5-4c5a-8fa7-968e5ad72050

Adalimumab

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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
2025-10-21
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Adalimumab-adaz use and during therapy. Initiate treatment for latent TB prior to Adalimumab-adaz use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with Adalimumab-adaz prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with Adalimumab-adaz, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [ see Warnings and Precautions ( 5.2 ) ]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 )]. WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting Adalimumab-adaz. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use : Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimumab-adaz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adaz can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-adaz can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis Adalimumab-adaz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease Adalimumab-adaz is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis Adalimumab-adaz is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14.7) ] . 1.7 Plaque Psoriasis Adalimumab-adaz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adaz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa Adalimumab-adaz is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis Adalimumab-adaz is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
  2. 1.6 Ulcerative Colitis Adalimumab-adaz is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14.7) ] .
  3. 1.7 Plaque Psoriasis Adalimumab-adaz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adaz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] .
Full extracted label fields
application numbers
  1. BLA761071
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Adalimumab-adaz use and during therapy. Initiate treatment for latent TB prior to Adalimumab-adaz use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with Adalimumab-adaz prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with Adalimumab-adaz, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [ see Warnings and Precautions ( 5.2 ) ]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 )]. WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting Adalimumab-adaz. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.
brand names
  1. Adalimumab
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3468792f-63ef-4916-8ed1-8214f327d9dd
generic names
  1. ADALIMUMAB-ADAZ
id
ae54abc4-e9c5-4c5a-8fa7-968e5ad72050
indications and usage exact
  1. 1 INDICATIONS AND USAGE Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use : Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimumab-adaz can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adaz can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-adaz can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis Adalimumab-adaz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease Adalimumab-adaz is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis Adalimumab-adaz is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14.7) ] . 1.7 Plaque Psoriasis Adalimumab-adaz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adaz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa Adalimumab-adaz is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis Adalimumab-adaz is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
  2. 1.6 Ulcerative Colitis Adalimumab-adaz is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers [see Clinical Studies (14.7) ] .
  3. 1.7 Plaque Psoriasis Adalimumab-adaz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adaz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] .
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Sandoz Inc
    matched search terms
    1. tumor
    package ndcs
    1. 61314-327-64
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    3. 61314-332-64
    4. 61314-325-20
    5. 61314-391-64
    product ndcs
    1. 61314-325
    2. 61314-327
    3. 61314-332
    4. 61314-391
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Hidradenitis Suppurativa ( 1.8 ) 10/2025 Indications and Usage, Uveitis ( 1.9 ) 10/2025 Dosage and Administration, Uveitis ( 2.3 ) 10/2025 Dosage and Administration, Hidradenitis Suppurativa ( 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025
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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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    url
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    source url
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    spl effective date
    2025-10-21
    spl effective time
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    spl set id
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    spl version
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    substance names
    1. ADALIMUMAB
    uniis
    1. FYS6T7F842
    verification flags
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    2. spl_text_not_verified_identical_to_latest_approved_label
    3. individual_indications_not_split_or_reconciled
    Drugs@FDA application source records
    1. application number
      BLA761071
      payload
      all indexed label documents
      1. Appl No
        761071
        Application Docs Date
        2018-10-31 00:00:00
        Application Docs ID
        56201
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761071
        Application Docs Date
        2021-02-26 00:00:00
        Application Docs ID
        66408
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        761071
        Application Docs Date
        2022-03-29 00:00:00
        Application Docs ID
        70646
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      4. Appl No
        761071
        Application Docs Date
        2022-07-20 00:00:00
        Application Docs ID
        71611
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      5. Appl No
        761071
        Application Docs Date
        2022-07-20 00:00:00
        Application Docs ID
        71612
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      6. Appl No
        761071
        Application Docs Date
        2023-03-27 00:00:00
        Application Docs ID
        73866
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      7. Appl No
        761071
        Application Docs Date
        2023-04-17 00:00:00
        Application Docs ID
        74005
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        15
        Submission Type
        SUPPL
      8. Appl No
        761071
        Application Docs Date
        2023-09-13 00:00:00
        Application Docs ID
        75442
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      9. Appl No
        761071
        Application Docs Date
        2024-04-09 00:00:00
        Application Docs ID
        78097
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        19
        Submission Type
        SUPPL
      10. Appl No
        761071
        Application Docs Date
        2024-06-13 00:00:00
        Application Docs ID
        78795
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      11. Appl No
        761071
        Application Docs Date
        2025-05-20 00:00:00
        Application Docs ID
        82231
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        22
        Submission Type
        SUPPL
      12. Appl No
        761071
        Application Docs Date
        2025-07-30 00:00:00
        Application Docs ID
        82990
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        24
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761071
        Review Priority
        Submission Class Code ID
        28
        Submission No
        31
        Submission Status
        AP
        Submission Status Date
        2025-10-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        24
        Submission Status
        AP
        Submission Status Date
        2025-07-29 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761071
        Review Priority
        N/A
        Submission Class Code ID
        6
        Submission No
        22
        Submission Status
        AP
        Submission Status Date
        2025-05-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2024-06-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761071
        Review Priority
        UNKNOWN
        Submission Class Code ID
        1
        Submission No
        19
        Submission Status
        AP
        Submission Status Date
        2024-04-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761071
        Review Priority
        N/A
        Submission Class Code ID
        1
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2023-09-08 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        19
        Submission No
        15
        Submission Status
        AP
        Submission Status Date
        2023-04-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2023-03-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2022-07-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        761071
        Review Priority
        N/A
        Submission Class Code ID
        4
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2022-03-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2022-07-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2021-02-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761071
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2025-10-16
      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
        761071
        Application Docs Date
        2025-10-21 00:00:00
        Application Docs ID
        83834
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        31
        Submission Type
        SUPPL
      official application record
      Appl No
      761071
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      SANDOZ INC
      openfda application present
      true
      products
      1. Active Ingredient
        ADALIMUMAB-ADAZ
        Appl No
        761071
        Drug Name
        HYRIMOZ
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        40MG/0.8ML
        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 · indication intro context
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    1 INDICATIONS AND USAGE Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active
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          1 INDICATIONS AND USAGE Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for:
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          1 INDICATIONS AND USAGE Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) • Reducing signs and symptoms, inhibiting
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              • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
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              symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) • Reducing signs and symptoms, inhibiting the pr
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                    ms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) • Reducing signs and sym
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                        erately to severely active rheumatoid arthritis. (1.1) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) • Reducing signs and symptoms
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                                                                                                                le Idiopathic Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adaz can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-adaz is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active ps
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                                                                                                                                                  1.7 Plaque Psoriasis Adalimumab-adaz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
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                                                                                                                                                  treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adaz should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa Adalimumab-adaz is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis Adalimumab-adaz is indica
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                                                                                                                                                            1.8 Hidradenitis Suppurativa Adalimumab-adaz is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
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