Application 020571

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	Yes	Yes
002	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/5ML (20MG/ML)	Yes	Yes
003	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	300MG/15ML (20MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020571-001	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14
N020571-002	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14
N020571-003	CAMPTOSAR	IRINOTECAN HYDROCHLORIDE	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020571-001	AP
N020571-002	AP
N020571-003	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020571-001	CAMPTOSAR	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020571-002	CAMPTOSAR	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	1996-06-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020571-003	CAMPTOSAR	300MG/15ML (20MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2010-08-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020571-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020571-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020571-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020571-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020571-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020571-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020571-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020571-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020571-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020571-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020571-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020571-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020571-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020571-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020571-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020571-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020571-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020571-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020571-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020571-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020571-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020571-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020571-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020571-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020571-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020571-001	AP	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020571-001	6403569	2020-04-28	U-449		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-001	6794370	2020-05-01	U-606		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6403569	2020-04-28	U-449		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6794370	2020-05-01	U-606		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6403569	2020-04-28	U-449		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6794370	2020-05-01	U-606		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6403569	2020-04-28	U-449		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6794370	2020-05-01	U-606		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6403569	2020-04-28	U-449		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6794370	2020-05-01	U-606		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6403569	2020-04-28	U-449		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6794370	2020-05-01	U-606		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6403569	2020-04-28	U-449		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6794370	2020-05-01	U-606		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6403569	2020-04-28	U-449		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6794370	2020-05-01	U-606		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6403569	2020-04-28	U-449		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6794370	2020-05-01	U-606		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6403569*PED	2020-10-28		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-001	6794370*PED	2020-11-01		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6403569	2020-04-28	U-449		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6794370	2020-05-01	U-606		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6403569*PED	2020-10-28		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020571-002	6794370*PED	2020-11-01		Pediatric extension	`b00525d2431f…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Camptosar	IRINOTECAN HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	e518dfc6-7e93-4fee-a66c-51e1ab71c056	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020571 application number: NDA020571 ndc (product): 0009-7529

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-1111	Camptosar	irinotecan hydrochloride	Pharmacia and Upjohn Comp	NDA	Current
0009-7529	Camptosar	irinotecan hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7529	Camptosar	irinotecan hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7529	Camptosar	irinotecan hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
0009-7529	Camptosar	irinotecan hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-7529	Camptosar	irinotecan hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78498	SUPPL	2024-05-20
78497	SUPPL	2024-05-20
69998	SUPPL	2022-01-31
69990	SUPPL	2022-01-31
61750	SUPPL	2020-01-31
61746	SUPPL	2020-01-31
57797	SUPPL	2019-02-25
57664	ORIG	2019-02-15
12756	SUPPL	2015-01-09
2762	SUPPL	2014-12-23
34870	SUPPL	2012-07-25
25213	SUPPL	2012-07-17
34869	SUPPL	2010-05-28
34868	SUPPL	2010-05-28
12755	SUPPL	2010-05-28
12754	SUPPL	2010-05-28
12753	SUPPL	2010-05-28
25212	SUPPL	2010-05-21
25211	SUPPL	2010-05-21
2761	SUPPL	2010-05-21
2760	SUPPL	2010-05-21
2759	SUPPL	2010-05-21
41439	SUPPL	2007-07-06
20731	SUPPL	2007-07-06
34867	SUPPL	2006-08-04
2758	SUPPL	2006-08-04
34866	SUPPL	2005-07-26
34865	SUPPL	2005-07-26
25210	SUPPL	2005-07-26
12752	SUPPL	2005-07-26
2757	SUPPL	2005-07-26
2755	SUPPL	2005-07-26
12751	SUPPL	2005-06-08
2756	SUPPL	2005-06-08
20732	SUPPL	2005-04-05
34864	SUPPL	2004-12-08
25209	SUPPL	2004-12-08
34863	SUPPL	2004-06-25
25208	SUPPL	2004-06-25
25207	SUPPL	2002-05-16
12750	SUPPL	2002-05-16
41441	SUPPL	2000-04-20
34862	SUPPL	2000-04-20
25206	SUPPL	2000-04-20
41440	SUPPL	1998-10-22
25205	SUPPL	1998-10-22
12749	SUPPL	1998-10-22
53105	SUPPL	1900-01-01
53104	SUPPL	1900-01-01
53103	SUPPL	1900-01-01