LABELS · 7e2a2a05-9122-41c0-acf0-a1231a57434e

BELRAPZO

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: 2024-09-23
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE BELRAPZO 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) BELRAPZO 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) BELRAPZO 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

NDA205580

boxed warning exact

brand names

BELRAPZO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9759a4ae-82ca-40cf-9c02-e1cadb21cbdc

generic names

BENDAMUSTINE HYDROCHLORIDE

7e2a2a05-9122-41c0-acf0-a1231a57434e

indications and usage exact

1 INDICATIONS AND USAGE BELRAPZO 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) BELRAPZO 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) BELRAPZO 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

Eagle Pharmaceuticals, Inc

matched search terms

lymphoma
leukemia

package ndcs

42367-521-25

product ndcs

42367-521

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1726097
2178266

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00400.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

license

https://open.fda.gov/license/

results

limit: 100
skip: 400
total: 830

terms

https://open.fda.gov/terms/

sha256

a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%227e2a2a05-9122-41c0-acf0-a1231a57434e%22

spl effective date

2024-09-23

spl effective time

20240923

spl set id

9759a4ae-82ca-40cf-9c02-e1cadb21cbdc

spl version

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
NDA205580
payload
all indexed label documents
Appl No
205580
Application Docs Date
2018-05-23 00:00:00
Application Docs ID
54226
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s000lbl.pdf
Submission No
1
Submission Type
ORIG
Appl No
205580
Application Docs Date
2018-12-13 00:00:00
Application Docs ID
56730
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205580s002lbl.pdf
Submission No
2
Submission Type
SUPPL
Appl No
205580
Application Docs Date
2019-10-31 00:00:00
Application Docs ID
60756
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205580s006lbl.pdf
Submission No
6
Submission Type
SUPPL
Appl No
205580
Application Docs Date
2021-10-15 00:00:00
Application Docs ID
69001
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205580s010lbl.pdf
Submission No
10
Submission Type
SUPPL
Appl No
205580
Application Docs Date
2023-07-31 00:00:00
Application Docs ID
71215
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205580Orig1s012lbl.pdf
Submission No
12
Submission Type
SUPPL
Appl No
205580
Application Docs Date
2024-01-16 00:00:00
Application Docs ID
77227
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205580s013lbl.pdf
Submission No
13
Submission Type
SUPPL
all submission records
Appl No
205580
Review Priority
STANDARD
Submission Class Code ID
15
Submission No
1
Submission Status
AP
Submission Status Date
2018-05-15 00:00:00
Submission Type
ORIG
Submissions Public Notes
Appl No
205580
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
2
Submission Status
AP
Submission Status Date
2018-08-31 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205580
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
6
Submission Status
AP
Submission Status Date
2019-10-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205580
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
10
Submission Status
AP
Submission Status Date
2021-10-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205580
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
12
Submission Status
AP
Submission Status Date
2022-06-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
205580
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
13
Submission Status
AP
Submission Status Date
2024-01-11 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA205580
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=205580
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
205580
Application Docs Date
2024-01-16 00:00:00
Application Docs ID
77227
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205580s013lbl.pdf
Submission No
13
Submission Type
SUPPL
official application record
Appl No
205580
Appl Public Notes
Appl Type
NDA
Sponsor Name
EAGLE PHARMS
openfda application present
true
products
Active Ingredient
BENDAMUSTINE HYDROCHLORIDE
Appl No
205580
Drug Name
BELRAPZO
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 classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

NDA205580

brand names

BELRAPZO

classification reasons

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tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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content role

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context span

end: 332
end exclusive: true
exact text: 1 INDICATIONS AND USAGE BELRAPZO 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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current approval status

not_reconciled

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extraction review status

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generic names

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positive predicate support span

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exact text: is an alkylating drug indicated
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qualifier mentions

context exact
1 INDICATIONS AND USAGE BELRAPZO is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
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source text sha256
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regulatory links

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source defined aliases

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exact text: 1 INDICATIONS AND USAGE BELRAPZO is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
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start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%227e2a2a05-9122-41c0-acf0-a1231a57434e%22

spl effective date

2024-09-23

spl set id

9759a4ae-82ca-40cf-9c02-e1cadb21cbdc

spl version

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 2 · limitation of use

application numbers

NDA205580

brand names

BELRAPZO

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 424
end exclusive: true
exact text: 1 INDICATIONS AND USAGE BELRAPZO 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
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source text sha256: 7529aae5791cb7f2676a26bf7dc6fb122460cc84b283a77dc39ff863d98ca54b
start: 0

current approval status

not_reconciled

duplicate text group

dup-4c2be900233cbf83f6b6

extraction review status

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generic names

BENDAMUSTINE HYDROCHLORIDE

ind-span-eeee1780be72edc8a185

label id

7e2a2a05-9122-41c0-acf0-a1231a57434e

positive predicate support span

Source null

qualifier mentions

context exact
Efficacy relative to first line therapies other than chlorambucil has not been established.
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exact text
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source text sha256
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start
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regulatory links

schema version

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source batch sha256

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source defined aliases

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end exclusive: true
exact text: Efficacy relative to first line therapies other than chlorambucil has not been established.
label id: 7e2a2a05-9122-41c0-acf0-a1231a57434e
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 7529aae5791cb7f2676a26bf7dc6fb122460cc84b283a77dc39ff863d98ca54b
start: 133

source url

https://api.fda.gov/drug/label.json?search=id%3A%227e2a2a05-9122-41c0-acf0-a1231a57434e%22

spl effective date

2024-09-23

spl set id

9759a4ae-82ca-40cf-9c02-e1cadb21cbdc

spl version

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

not_applicable

Passage 3 · unclassified context

application numbers

NDA205580

brand names

BELRAPZO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 586
end exclusive: true
exact text: ELRAPZO 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) BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil
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offset unit: unicode_code_points
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current approval status

not_reconciled

duplicate text group

dup-2354f5b27e7b8db48ed6

extraction review status

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generic names

BENDAMUSTINE HYDROCHLORIDE

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7e2a2a05-9122-41c0-acf0-a1231a57434e

positive predicate support span

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qualifier mentions

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exact text: ( 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.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%227e2a2a05-9122-41c0-acf0-a1231a57434e%22

spl effective date

2024-09-23

spl set id

9759a4ae-82ca-40cf-9c02-e1cadb21cbdc

spl version

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 4 · unclassified context

application numbers

NDA205580

brand names

BELRAPZO

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

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content role

unclassified_context

context span

end: 594
end exclusive: true
exact text: 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) BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not
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exact text: ( 1.2 )
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source url

https://api.fda.gov/drug/label.json?search=id%3A%227e2a2a05-9122-41c0-acf0-a1231a57434e%22

spl effective date

2024-09-23

spl set id

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spl version

structured fields status

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structured indication

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limitations: Source null
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prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Passage 5 · positive indication candidate

application numbers

NDA205580

brand names

BELRAPZO

classification reasons

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tumor_or_malignant_hematology_words_in_positive_statement

clinical review status

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context span

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exact text: cil 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) BELRAPZO 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) BELRAPZO is indicated for the treatment of patients with indolent B-cell non
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qualifier mentions

regulatory links

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exact text: 1.1 Chronic Lymphocytic Leukemia (CLL) BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia.
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source url

https://api.fda.gov/drug/label.json?search=id%3A%227e2a2a05-9122-41c0-acf0-a1231a57434e%22

spl effective date

2024-09-23

spl set id

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spl version

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 6 · limitation of use

application numbers

NDA205580

brand names

BELRAPZO

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 812
end exclusive: true
exact text: hs of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) BELRAPZO 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) BELRAPZO 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 rituxima
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source url

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prior therapy: Source null
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use intent

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Passage 7 · positive indication candidate

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exact text: cytic Leukemia (CLL) BELRAPZO 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) BELRAPZO 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.
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exact text: 1.2 Non-Hodgkin Lymphoma (NHL) BELRAPZO 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.
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source url

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spl effective date

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structured indication

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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

Preserved source evidence · Not medical advice