Application 091032

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	No	No
002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/5ML (20MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091032-001	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP		2010-12-20
A091032-002	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP		2010-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091032-001	AP
A091032-002	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 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091032-001	IRINOTECAN HYDROCHLORIDE	40MG/2ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091032-002	IRINOTECAN HYDROCHLORIDE	100MG/5ML (20MG/ML)	INJECTABLE / INJECTION	AP	2010-12-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091032-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091032-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091032-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091032-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091032-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091032-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091032-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091032-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091032-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091032-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091032-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091032-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091032-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091032-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091032-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091032-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091032-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091032-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091032-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091032-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091032-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091032-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091032-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091032-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091032-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091032-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091032-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091032-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091032-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091032-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091032-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091032-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091032-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091032-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091032-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091032-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091032-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091032-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091032-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091032-002	AP	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	9c6aa884-750e-4b11-9955-bc7ab6e9c2ad	2020-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091032 application number: ANDA091032 ndc (product): 0143-9583
Irinotecan Hydrochloride	IRINOTECAN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	be716692-6b4f-47b6-83d1-01665861626b	2020-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091032 application number: ANDA091032 ndc (product): 0143-9702 ndc (product): 0143-9701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9583	Irinotecan Hydrochloride	Irinotecan Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9583	Irinotecan Hydrochloride	Irinotecan Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9583	Irinotecan Hydrochloride	Irinotecan Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9701	Irinotecan Hydrochloride	Irinotecan Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9701	Irinotecan Hydrochloride	Irinotecan Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9701	Irinotecan Hydrochloride	Irinotecan Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9702	Irinotecan Hydrochloride	Irinotecan Hydrochloride	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9702	Irinotecan Hydrochloride	Irinotecan Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9702	Irinotecan Hydrochloride	Irinotecan Hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current