Application 216793

Type: NDA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	TABLET;ORAL	500MG;EQ 50MG BASE	Yes	No
002	AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	TABLET;ORAL	500MG;EQ 100MG BASE	Yes	Yes

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

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
N216793-001	AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	500MG;EQ 50MG BASE	TABLET / ORAL		RLD	2023-08-11
N216793-002	AKEEGA	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE	500MG;EQ 100MG BASE	TABLET / ORAL		RLD, RS	2023-08-11

Orange Book patents#

Current patent rows page 1 of 1 · 44 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216793-001	8071579	2027-08-12	U-2830		2023-09-06
N216793-001	8071579	2027-08-12	U-4368		2023-09-06
N216793-001	8143241	2027-08-12	U-2830		2023-09-06
N216793-001	8143241	2027-08-12	U-4368		2023-09-06
N216793-001	8436185	2029-04-24		Drug substance, Drug product	2023-09-06
N216793-001	8071623	2031-03-27		Drug substance, Drug product	2023-09-06
N216793-001	8859562	2031-08-04	U-2830		2023-09-06
N216793-001	8859562	2031-08-04	U-4368		2023-09-06
N216793-001	11207311	2037-07-28	U-2830		2023-09-06
N216793-001	11207311	2037-07-28	U-4368		2023-09-06
N216793-001	11986468	2037-07-28	U-2830		2024-07-02
N216793-001	11986468	2037-07-28	U-4368		2024-07-02
N216793-001	11986469	2037-07-28	U-2830		2024-07-02
N216793-001	11986469	2037-07-28	U-4368		2024-07-02
N216793-001	11986470	2037-07-28	U-4368		2026-01-09
N216793-001	11992486	2037-07-28	U-2830		2024-07-02
N216793-001	11992486	2037-07-28	U-4368		2024-07-02
N216793-001	12383543	2037-07-28	U-2830		2025-09-11
N216793-001	12383543	2037-07-28	U-4368		2025-09-11
N216793-001	11091459	2038-03-27		Drug substance, Drug product	2023-09-06
N216793-001	11673877	2038-03-27	U-2830	Drug substance, Drug product	2023-09-06
N216793-001	11673877	2038-03-27	U-4368	Drug substance, Drug product	2023-09-06
N216793-002	8071579	2027-08-12	U-2830		2023-09-06
N216793-002	8071579	2027-08-12	U-4368		2023-09-06
N216793-002	8143241	2027-08-12	U-2830		2023-09-06
N216793-002	8143241	2027-08-12	U-4368		2023-09-06
N216793-002	8436185	2029-04-24		Drug substance, Drug product	2023-09-06
N216793-002	8071623	2031-03-27		Drug substance, Drug product	2023-09-06
N216793-002	8859562	2031-08-04	U-2830		2023-09-06
N216793-002	8859562	2031-08-04	U-4368		2023-09-06
N216793-002	11207311	2037-07-28	U-2830		2023-09-06
N216793-002	11207311	2037-07-28	U-4368		2023-09-06
N216793-002	11986468	2037-07-28	U-2830		2024-07-02
N216793-002	11986468	2037-07-28	U-4368		2024-07-02
N216793-002	11986469	2037-07-28	U-2830		2024-07-02
N216793-002	11986469	2037-07-28	U-4368		2024-07-02
N216793-002	11986470	2037-07-28	U-4368		2026-01-09
N216793-002	11992486	2037-07-28	U-2830		2024-07-02
N216793-002	11992486	2037-07-28	U-4368		2024-07-02
N216793-002	12383543	2037-07-28	U-2830		2025-09-11
N216793-002	12383543	2037-07-28	U-4368		2025-09-11
N216793-002	11091459	2038-03-27		Drug substance, Drug product	2023-09-06
N216793-002	11673877	2038-03-27	U-2830	Drug substance, Drug product	2023-09-06
N216793-002	11673877	2038-03-27	U-4368	Drug substance, Drug product	2023-09-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216793-001	NP	2026-08-11
N216793-001	I-980	2028-12-12
N216793-002	NP	2026-08-11
N216793-002	I-980	2028-12-12

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.

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	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-001	AKEEGA	500MG;EQ 50MG BASE	TABLET / ORAL	RLD	2023-08-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-002	AKEEGA	500MG;EQ 100MG BASE	TABLET / ORAL	RLD, RS	2023-08-11	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 444 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	N216793-001	8071579	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8071579	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8143241	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8143241	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8436185	2029-04-24		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8071623	2031-03-27		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8859562	2031-08-04	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	8859562	2031-08-04	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11207311	2037-07-28	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11207311	2037-07-28	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986468	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986468	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986469	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986469	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11986470	2037-07-28	U-4368		2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11992486	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11992486	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	12383543	2037-07-28	U-4368		2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	12383543	2037-07-28	U-2830		2025-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11091459	2038-03-27		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11673877	2038-03-27	U-2830	Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	11673877	2038-03-27	U-4368	Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8071579	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8071579	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8143241	2027-08-12	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8143241	2027-08-12	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8436185	2029-04-24		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8071623	2031-03-27		Drug substance, Drug product	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8859562	2031-08-04	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	8859562	2031-08-04	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11207311	2037-07-28	U-2830		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11207311	2037-07-28	U-4368		2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986468	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986468	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986469	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986469	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11986470	2037-07-28	U-4368		2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11992486	2037-07-28	U-4368		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	11992486	2037-07-28	U-2830		2024-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	12383543	2037-07-28	U-4368		2025-09-11	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 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	N216793-001	NP	2026-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-001	I-980	2028-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	NP	2026-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216793-002	I-980	2028-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-001	NP	2026-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216793-002	NP	2026-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216793-001	NP	2026-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216793-002	NP	2026-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-001	NP	2026-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216793-002	NP	2026-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-001	NP	2026-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216793-002	NP	2026-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-001	NP	2026-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216793-002	NP	2026-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-001	NP	2026-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216793-002	NP	2026-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-001	NP	2026-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216793-002	NP	2026-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-001	NP	2026-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216793-002	NP	2026-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216793-001	NP	2026-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216793-002	NP	2026-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-001	NP	2026-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216793-002	NP	2026-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-001	NP	2026-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216793-002	NP	2026-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-001	NP	2026-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216793-002	NP	2026-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216793-001	NP	2026-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216793-002	NP	2026-08-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-001	NP	2026-08-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216793-002	NP	2026-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216793-001	NP	2026-08-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216793-002	NP	2026-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216793-001	NP	2026-08-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216793-002	NP	2026-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-001	NP	2026-08-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216793-002	NP	2026-08-11	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-001	NP	2026-08-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216793-001	I-980	2028-12-12	`a50c72e98297…`

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
AKEEGA	NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE	Janssen Biotech, Inc.	8245a990-3268-4613-b5c5-9537858a1eb9	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216793 application number: NDA216793

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84447	SUPPL	2025-12-18
84413	SUPPL	2025-12-15
84412	SUPPL	2025-12-15
78608	ORIG	2024-06-03
75062	ORIG	2023-08-14
75056	ORIG	2023-08-14