LABELS · bcfd315e-9ade-4659-9f1c-dfb687ba39de
Bendeka
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
- 2024-01-19
- Captured
- 2026-09-09T23:37:58.719708+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source text
- 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Full extracted label fields
- application numbers
- NDA208194
- boxed warning exact
- brand names
- Bendeka
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ace9a43b-f9bd-4896-abfe-0ef4fec67ddf
- generic names
- BENDAMUSTINE HYDROCHLORIDE
- id
- bcfd315e-9ade-4659-9f1c-dfb687ba39de
- indications and usage exact
- 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BENDEKA is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- Teva Pharmaceuticals USA, Inc.
- matched search terms
- lymphoma
- leukemia
- package ndcs
- 63459-348-04
- product ndcs
- 63459-348
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- record type
- complete_spl_indications_section_candidate
- routes
- INTRAVENOUS
- rxcuis
- 1726097
- 1726102
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00600.json
- 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.
- last updated
- 2026-09-09
- results
- limit
- 100
- skip
- 600
- total
- 830
- sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22bcfd315e-9ade-4659-9f1c-dfb687ba39de%22
- spl effective date
- 2024-01-19
- spl effective time
- 20240119
- spl set id
- ace9a43b-f9bd-4896-abfe-0ef4fec67ddf
- spl version
- 22
- substance names
- BENDAMUSTINE HYDROCHLORIDE
- uniis
- 981Y8SX18M
- verification flags
- oncology_keyword_candidate_not_clinically_classified
- spl_text_not_verified_identical_to_latest_approved_label
- individual_indications_not_split_or_reconciled
Drugs@FDA application source records
- application number
- NDA208194
- payload
- all indexed label documents
- Appl No
- 208194
- Application Docs Date
- 2015-12-08 00:00:00
- Application Docs ID
- 19987
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208194s000lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 208194
- Application Docs Date
- 2016-08-02 00:00:00
- Application Docs ID
- 40623
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf
- Submission No
- 1
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2016-06-27 00:00:00
- Application Docs ID
- 40624
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208194s001s002lbl.pdf
- Submission No
- 2
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2017-02-10 00:00:00
- Application Docs ID
- 47169
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208194s005lbl.pdf
- Submission No
- 5
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2018-07-31 00:00:00
- Application Docs ID
- 55065
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208194s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2019-10-15 00:00:00
- Application Docs ID
- 60572
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s019lbl.pdf
- Submission No
- 19
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2019-12-12 00:00:00
- Application Docs ID
- 61244
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208194s020lbl.pdf
- Submission No
- 20
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2021-10-15 00:00:00
- Application Docs ID
- 69000
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208194s024lbl.pdf
- Submission No
- 24
- Submission Type
- SUPPL
- Appl No
- 208194
- Application Docs Date
- 2024-01-16 00:00:00
- Application Docs ID
- 77228
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208194s026lbl.pdf
- Submission No
- 26
- Submission Type
- SUPPL
- all submission records
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 15
- Submission No
- 1
- Submission Status
- AP
- Submission Status Date
- 2015-12-07 00:00:00
- Submission Type
- ORIG
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 1
- Submission Status
- AP
- Submission Status Date
- 2016-06-23 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 2
- Submission Status
- AP
- Submission Status Date
- 2016-06-23 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- UNKNOWN
- Submission Class Code ID
- 19
- Submission No
- 3
- Submission Status
- AP
- Submission Status Date
- 2016-09-23 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 19
- Submission No
- 4
- Submission Status
- AP
- Submission Status Date
- 2017-02-06 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 5
- Submission Status
- AP
- Submission Status Date
- 2017-02-09 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 13
- Submission Status
- AP
- Submission Status Date
- 2018-07-30 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 19
- Submission Status
- AP
- Submission Status Date
- 2019-10-08 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 20
- Submission Status
- AP
- Submission Status Date
- 2019-11-08 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 24
- Submission Status
- AP
- Submission Status Date
- 2021-10-14 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 208194
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 26
- Submission Status
- AP
- Submission Status Date
- 2024-01-11 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- application number
- NDA208194
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208194
- has approved submission record
- true
- latest approved submission date
- 2024-01-11
- 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
- Appl No
- 208194
- Application Docs Date
- 2024-01-16 00:00:00
- Application Docs ID
- 77228
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208194s026lbl.pdf
- Submission No
- 26
- Submission Type
- SUPPL
- official application record
- Appl No
- 208194
- Appl Public Notes
- Appl Type
- NDA
- Sponsor Name
- EAGLE PHARMS
- openfda application present
- true
- products
- Active Ingredient
- BENDAMUSTINE HYDROCHLORIDE
- Appl No
- 208194
- Drug Name
- BENDEKA
- Form
- SOLUTION;INTRAVENOUS
- Product No
- 001
- Reference Drug
- 1
- Reference Standard
- 1
- Strength
- 100MG/4ML (25MG/ML)
- marketing status
- Prescription
Source passages and status connections
Passage 1 · positive indication candidate
- application numbers
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- exact text
- 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treat
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- qualifier mentions
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- 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
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- 91
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- alkylating drug indicated for treatment of
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- 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
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- source url
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- spl effective date
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- spl set id
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- spl version
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- structured fields status
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- Source null
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- Source null
- biomarker and test
- Source null
- disease stage
- Source null
- limitations
- Source null
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- Source null
- prior therapy
- Source null
- regimen
- Source null
- tumor histology
- Source null
- use intent
- tumor_directed_candidate
Passage 2 · limitation of use
- application numbers
- NDA208194
- brand names
- Bendeka
- classification reasons
- negative_or_not_established_clause
- clinical review status
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- content role
- limitation_of_use
- context span
- end
- 433
- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE BENDEKA injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leuke
- label id
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- generic names
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- id
- ind-span-eb185ca9a4c37848d3fd
- label id
- bcfd315e-9ade-4659-9f1c-dfb687ba39de
- positive predicate support span
- Source null
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- Efficacy relative to first line therapies other than chlorambucil has not been established.
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- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22bcfd315e-9ade-4659-9f1c-dfb687ba39de%22
- spl effective date
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- spl set id
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- Source null
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- 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
- not_applicable
Passage 3 · unclassified context
- application numbers
- NDA208194
- brand names
- Bendeka
- classification reasons
- no_unambiguous_positive_indication_predicate
- clinical review status
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- content role
- unclassified_context
- context span
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- end exclusive
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- exact text
- jection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambuci
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- Source null
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- Source null
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- Source null
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- Source null
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- Source null
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- Source null
- use intent
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Passage 4 · unclassified context
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- hlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA ® is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has no
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Passage 5 · positive indication candidate
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Passage 6 · limitation of use
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Preserved source evidence · Not medical advice
Triangle