LABELS · 6f05fe24-191a-4273-ad62-4ab6b5324062

Camptosar

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: 2026-05-12
Captured: 2026-09-09T23:37:51.659493+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: DIARRHEA and MYELOSUPPRESSION • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Severe myelosuppression may occur [see Warnings and Precautions (5.2) ] . WARNING: DIARRHEA and MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs. ( 2.2 , 5.1 ) • Severe myelosuppression may occur. ( 5.2 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE • CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )

Full extracted label fields

application numbers

NDA020571

boxed warning exact

WARNING: DIARRHEA and MYELOSUPPRESSION • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Severe myelosuppression may occur [see Warnings and Precautions (5.2) ] . WARNING: DIARRHEA and MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs. ( 2.2 , 5.1 ) • Severe myelosuppression may occur. ( 5.2 )

brand names

Camptosar

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e518dfc6-7e93-4fee-a66c-51e1ab71c056

generic names

IRINOTECAN HYDROCHLORIDE

6f05fe24-191a-4273-ad62-4ab6b5324062

indications and usage exact

1 INDICATIONS AND USAGE • CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

Pharmacia & Upjohn Company LLC

matched search terms

carcinoma

package ndcs

0009-7529-04
0009-7529-03
0009-7529-05
0009-7529-10
0009-0112-05
0009-0082-02

product ndcs

0009-0082
0009-7529
0009-0112

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVENOUS

rxcuis

1726319
1726321
1726324
1726325
1726333
1726335

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%226f05fe24-191a-4273-ad62-4ab6b5324062%22

spl effective date

2026-05-12

spl effective time

20260512

spl set id

e518dfc6-7e93-4fee-a66c-51e1ab71c056

spl version

substance names

IRINOTECAN HYDROCHLORIDE

uniis

042LAQ1IIS

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
NDA020571
payload
all indexed label documents
Appl No
020571
Application Docs Date
1998-10-22 00:00:00
Application Docs ID
12749
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20571s8lbl.pdf
Submission No
8
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2002-05-16 00:00:00
Application Docs ID
12750
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20571s16lbl.pdf
Submission No
16
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2005-06-08 00:00:00
Application Docs ID
12751
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf
Submission No
26
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2005-07-26 00:00:00
Application Docs ID
12752
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf
Submission No
28
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2010-05-28 00:00:00
Application Docs ID
12753
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
Submission No
31
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2010-05-28 00:00:00
Application Docs ID
12754
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
Submission No
32
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2010-05-28 00:00:00
Application Docs ID
12755
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
Submission No
37
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2015-01-09 00:00:00
Application Docs ID
12756
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf
Submission No
48
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2000-04-20 00:00:00
Application Docs ID
34862
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20571s9lbl.pdf
Submission No
9
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2004-06-25 00:00:00
Application Docs ID
34863
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571se8-021_camptosar_lbl.pdf
Submission No
21
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2004-12-08 00:00:00
Application Docs ID
34864
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571s023lbl.pdf
Submission No
23
Submission Type
SUPPL
Appl No
020571
Application Docs Date
2005-07-26 00:00:00
Application Docs ID
34865
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf
Submission No
24
Submission Type
SUPPL
all submission records
Appl No
020571
Review Priority
N/A
Submission Class Code ID
4
Submission No
56
Submission Status
AP
Submission Status Date
2024-04-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
53
Submission Status
AP
Submission Status Date
2022-01-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
52
Submission Status
AP
Submission Status Date
2022-01-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
51
Submission Status
AP
Submission Status Date
2020-01-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
50
Submission Status
AP
Submission Status Date
2019-02-22 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
48
Submission Status
AP
Submission Status Date
2014-12-19 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
47
Submission Status
AP
Submission Status Date
2014-06-09 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
PRIORITY
Submission Class Code ID
4
Submission No
44
Submission Status
AP
Submission Status Date
2013-01-17 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
42
Submission Status
AP
Submission Status Date
2012-07-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
UNKNOWN
Submission Class Code ID
3
Submission No
37
Submission Status
AP
Submission Status Date
2010-05-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
36
Submission Status
AP
Submission Status Date
2010-05-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
020571
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
33
Submission Status
AP
Submission Status Date
2010-05-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA020571
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=020571
has approved submission record
true
latest approved submission date
2024-04-04
latest label selection rule
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latest posted label documents
Appl No
020571
Application Docs Date
2024-05-20 00:00:00
Application Docs ID
78497
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020571Orig1s056lbl.pdf
Submission No
56
Submission Type
SUPPL
official application record
Appl No
020571
Appl Public Notes
Appl Type
NDA
Sponsor Name
PFIZER INC
openfda application present
true
products
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Appl No
020571
Drug Name
CAMPTOSAR
Form
INJECTABLE;INJECTION
Product No
001
Reference Drug
1
Reference Standard
1
Strength
40MG/2ML (20MG/ML)
marketing status
Prescription
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Appl No
020571
Drug Name
CAMPTOSAR
Form
INJECTABLE;INJECTION
Product No
002
Reference Drug
1
Reference Standard
1
Strength
100MG/5ML (20MG/ML)
marketing status
Prescription
Active Ingredient
IRINOTECAN HYDROCHLORIDE
Appl No
020571
Drug Name
CAMPTOSAR
Form
INJECTABLE;INJECTION
Product No
003
Reference Drug
1
Reference Standard
1
Strength
300MG/15ML (20MG/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 · unclassified context

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brand names

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spl version

structured fields status

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

use intent

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Passage 2 · positive indication candidate

application numbers

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disease stage: Source null
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 3 · positive indication candidate

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exact text: NS AND USAGE • CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) • Pat
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