Application 214876

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEJULA	NIRAPARIB TOSYLATE	TABLET;ORAL	EQ 100MG BASE	Yes	No
002	ZEJULA	NIRAPARIB TOSYLATE	TABLET;ORAL	EQ 200MG BASE	Yes	No
003	ZEJULA	NIRAPARIB TOSYLATE	TABLET;ORAL	EQ 300MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214876-001	ZEJULA	NIRAPARIB TOSYLATE	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26
N214876-002	ZEJULA	NIRAPARIB TOSYLATE	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26
N214876-003	ZEJULA	NIRAPARIB TOSYLATE	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214876-001	8071579	2027-08-12	U-2655		2023-05-23
N214876-001	8143241	2027-08-12	U-2655		2023-05-23
N214876-001	8436185	2029-04-24		Drug substance	2023-05-23
N214876-001	8071623	2031-03-27		Drug substance, Drug product	2023-05-23
N214876-001	8859562	2031-08-04	U-2655		2023-05-23
N214876-001	11091459	2038-03-27		Drug product	2023-05-23
N214876-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N214876-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11
N214876-001	11730725	2039-01-25		Drug product	2023-09-21
N214876-002	8071579	2027-08-12	U-2655		2023-05-23
N214876-002	8143241	2027-08-12	U-2655		2023-05-23
N214876-002	8436185	2029-04-24		Drug substance	2023-05-23
N214876-002	8071623	2031-03-27		Drug substance, Drug product	2023-05-23
N214876-002	8859562	2031-08-04	U-2655		2023-05-23
N214876-002	11091459	2038-03-27		Drug product	2023-05-23
N214876-002	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N214876-002	11673877	2038-03-27	U-3647	Drug product	2023-07-11
N214876-002	11730725	2039-01-25		Drug product	2023-09-21
N214876-003	8071579	2027-08-12	U-2655		2023-05-23
N214876-003	8143241	2027-08-12	U-2655		2023-05-23
N214876-003	8436185	2029-04-24		Drug substance	2023-05-23
N214876-003	8071623	2031-03-27		Drug substance, Drug product	2023-05-23
N214876-003	8859562	2031-08-04	U-2655		2023-05-23
N214876-003	11091459	2038-03-27		Drug product	2023-05-23
N214876-003	11673877	2038-03-27	U-3646	Drug product	2023-07-11
N214876-003	11673877	2038-03-27	U-3647	Drug product	2023-07-11
N214876-003	11730725	2039-01-25		Drug product	2023-09-21

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 · 66 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	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214876-002	ZEJULA	EQ 200MG BASE	TABLET / ORAL	RLD	2023-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214876-003	ZEJULA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2023-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214876-001	ZEJULA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-04-26	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 582 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	N214876-001	8071579	2027-08-12	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	8143241	2027-08-12	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	8436185	2029-04-24		Drug substance	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	8859562	2031-08-04	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	11091459	2038-03-27		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-001	11730725	2039-01-25		Drug product	2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	8071579	2027-08-12	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	8143241	2027-08-12	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	8436185	2029-04-24		Drug substance	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	8859562	2031-08-04	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	11091459	2038-03-27		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-002	11730725	2039-01-25		Drug product	2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	8071579	2027-08-12	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	8143241	2027-08-12	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	8436185	2029-04-24		Drug substance	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	8859562	2031-08-04	U-2655		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	11091459	2038-03-27		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214876-003	11730725	2039-01-25		Drug product	2023-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	8071579	2027-08-12	U-2655		2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	8143241	2027-08-12	U-2655		2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	8436185	2029-04-24		Drug substance	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	8859562	2031-08-04	U-2655		2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	11091459	2038-03-27		Drug product	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	11673877	2038-03-27	U-3646	Drug product	2023-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	11673877	2038-03-27	U-3647	Drug product	2023-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-001	11730725	2039-01-25		Drug product	2023-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-002	8071579	2027-08-12	U-2655		2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-002	8143241	2027-08-12	U-2655		2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-002	8436185	2029-04-24		Drug substance	2023-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214876-002	8071623	2031-03-27		Drug substance, Drug product	2023-05-23	`31067a03dcf5…`

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
ZEJULA	NIRAPARIB	GlaxoSmithKline LLC	b7f675e2-159c-490c-b6f4-3f16d9492b7d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214876 application number: NDA214876

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85603	SUPPL	2026-03-31
85602	SUPPL	2026-03-31
83093	SUPPL	2025-08-12
82890	SUPPL	2025-07-21
82889	SUPPL	2025-07-21
82621	SUPPL	2025-06-20
82620	SUPPL	2025-06-20
82612	SUPPL	2025-06-20
82611	SUPPL	2025-06-20
76589	ORIG	2023-11-16
74100	ORIG	2023-04-27
74093	ORIG	2023-04-27