Application 207793

Type: NDA
Sponsor: IPSEN INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONIVYDE	IRINOTECAN HYDROCHLORIDE	INJECTABLE, LIPOSOMAL;INTRAVENOUS	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207793-001	ONIVYDE	IRINOTECAN HYDROCHLORIDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS		RLD, RS	2015-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207793-001	8329213	2027-01-06		Drug substance, Drug product	2015-11-18
N207793-001	8147867	2028-08-29		Drug substance, Drug product	2015-11-18
N207793-001	10980795	2033-06-12	U-1848		2021-05-11
N207793-001	11369597	2033-06-12	U-1848		2022-07-20
N207793-001	12364691	2033-06-12	U-1848		2025-08-07
N207793-001	9339497	2033-06-12	U-1848		2016-06-06
N207793-001	9364473	2033-06-12	U-1856		2016-06-24
N207793-001	9452162	2033-06-12	U-1899		2016-09-30
N207793-001	9492442	2033-06-12	U-1848		2016-12-02
N207793-001	9492442	2033-06-12	U-1899		2016-12-02
N207793-001	9492442	2033-06-12	U-1917		2016-12-02
N207793-001	9717724	2033-06-12	U-1848		2017-08-30
N207793-001	9717724	2033-06-12	U-2091		2017-08-30
N207793-001	11344552	2036-08-19	U-3824		2024-03-12
N207793-001	10456360	2036-10-15		Drug product	2019-11-25
N207793-001	10993914	2036-10-15		Drug product	2021-05-11
N207793-001	12059497	2036-10-15		Drug product	2024-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207793-001	I-932	2027-02-13
N207793-001	ODE-463	2031-02-13

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207793-001	ONIVYDE	EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)	INJECTABLE, LIPOSOMAL / INTRAVENOUS	RLD, RS	2015-10-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 800 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207793-001	8329213	2027-01-06		Drug substance, Drug product	2015-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	8147867	2028-08-29		Drug substance, Drug product	2015-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	10980795	2033-06-12	U-1848		2021-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	11369597	2033-06-12	U-1848		2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	12364691	2033-06-12	U-1848		2025-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9339497	2033-06-12	U-1848		2016-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9364473	2033-06-12	U-1856		2016-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9452162	2033-06-12	U-1899		2016-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9492442	2033-06-12	U-1917		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9492442	2033-06-12	U-1899		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9492442	2033-06-12	U-1848		2016-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9717724	2033-06-12	U-2091		2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	9717724	2033-06-12	U-1848		2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	11344552	2036-08-19	U-3824		2024-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	10456360	2036-10-15		Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	10993914	2036-10-15		Drug product	2021-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	12059497	2036-10-15		Drug product	2024-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10722508	2025-05-02		Drug substance, Drug product	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8703181	2025-05-02	U-1434		2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8992970	2025-05-02		Drug substance, Drug product	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9724303	2025-05-02		Drug substance, Drug product	2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9730891	2025-05-02	U-1848		2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9782349	2025-05-02		Drug substance, Drug product	2017-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8329213	2027-01-06		Drug substance, Drug product	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	8147867	2028-08-29		Drug substance, Drug product	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10980795	2033-06-12	U-1848		2021-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	11369597	2033-06-12	U-1848		2022-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	12364691	2033-06-12	U-1848		2025-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9339497	2033-06-12	U-1848		2016-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9364473	2033-06-12	U-1856		2016-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9452162	2033-06-12	U-1899		2016-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9492442	2033-06-12	U-1917		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9492442	2033-06-12	U-1899		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9492442	2033-06-12	U-1848		2016-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9717724	2033-06-12	U-2091		2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	9717724	2033-06-12	U-1848		2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	11344552	2036-08-19	U-3824		2024-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10456360	2036-10-15		Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	10993914	2036-10-15		Drug product	2021-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	12059497	2036-10-15		Drug product	2024-09-05	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207793-001	I-932	2027-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207793-001	ODE-463	2031-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	I-932	2027-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207793-001	ODE-463	2031-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207793-001	I-932	2027-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207793-001	ODE-463	2031-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207793-001	I-932	2027-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207793-001	ODE-463	2031-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207793-001	I-932	2027-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207793-001	ODE-463	2031-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207793-001	I-932	2027-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207793-001	ODE-463	2031-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207793-001	I-932	2027-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207793-001	ODE-463	2031-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207793-001	I-932	2027-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207793-001	ODE-463	2031-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207793-001	I-932	2027-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207793-001	ODE-463	2031-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207793-001	I-932	2027-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207793-001	ODE-463	2031-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207793-001	I-932	2027-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207793-001	ODE-463	2031-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207793-001	I-932	2027-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207793-001	ODE-463	2031-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207793-001	I-932	2027-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207793-001	ODE-463	2031-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207793-001	I-932	2027-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207793-001	ODE-463	2031-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207793-001	ODE-99	2022-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207793-001	ODE-99	2022-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207793-001	ODE-99	2022-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207793-001	ODE-99	2022-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207793-001	ODE-99	2022-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207793-001	ODE-99	2022-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207793-001	ODE-99	2022-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207793-001	ODE-99	2022-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207793-001	ODE-99	2022-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207793-001	ODE-99	2022-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207793-001	ODE-99	2022-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207793-001	ODE-99	2022-10-22	`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
Onivyde	IRINOTECAN HYDROCHLORIDE	Ipsen Biopharmaceuticals, Inc.	c8b58efa-1820-48a4-b70d-62918fc4abfc	2025-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207793 application number: NDA207793 ndc (product): 15054-0043

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
15054-0043	Onivyde	IRINOTECAN HYDROCHLORIDE	Ipsen Biopharmaceuticals, Inc.	NDA	Current
15054-0043	Onivyde	IRINOTECAN HYDROCHLORIDE	Ipsen Biopharmaceuticals, Inc.	NDA	Current
69171-398	Onivyde	Irinotecan hydrochloride	Merrimack Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80751	SUPPL	2024-12-27
80741	SUPPL	2024-12-27
77493	SUPPL	2024-02-14
77482	SUPPL	2024-02-13
73565	SUPPL	2023-02-21
73387	SUPPL	2023-02-06
46072	ORIG	2016-09-29
32861	ORIG	2015-10-26
19969	ORIG	2015-10-22