Home Applications 208447 Application 208447
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEJULA NIRAPARIB TOSYLATE CAPSULE;ORAL EQ 100MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N208447-001 ZEJULA NIRAPARIB TOSYLATE EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208447-001 8071579 2027-08-12 U-2655 2019-11-22 N208447-001 8143241 2027-08-12 U-2655 2019-11-22 N208447-001 8436185 2029-04-24 Drug substance 2017-04-24 N208447-001 8071623 2031-03-27 Drug substance, Drug product 2017-04-24 N208447-001 8859562 2031-08-04 U-2655 2019-11-22 N208447-001 11091459 2038-03-27 Drug product 2021-09-07 N208447-001 11673877 2038-03-27 U-3646 Drug product 2023-07-11 N208447-001 11673877 2038-03-27 U-3647 Drug product 2023-07-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208447-001 ODE-277 2026-10-23 N208447-001 ODE-295 2027-04-29
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 · 42 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 2026-08-18 06:07:40 2026-07 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD 2017-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208447-001 ZEJULA EQ 100MG BASE CAPSULE / ORAL RLD, RS 2017-03-27 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 7 · 279 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208447-001 8071579 2027-08-12 U-2655 2019-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 8143241 2027-08-12 U-2655 2019-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 8436185 2029-04-24 Drug substance 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 8071623 2031-03-27 Drug substance, Drug product 2017-04-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 8859562 2031-08-04 U-2655 2019-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 11091459 2038-03-27 Drug product 2021-09-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 11673877 2038-03-27 U-3646 Drug product 2023-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208447-001 11673877 2038-03-27 U-3647 Drug product 2023-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208447-001 8071579 2027-08-12 U-2655 2019-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 8143241 2027-08-12 U-2655 2019-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 8436185 2029-04-24 Drug substance 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 8071623 2031-03-27 Drug substance, Drug product 2017-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 8859562 2031-08-04 U-2655 2019-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 11091459 2038-03-27 Drug product 2021-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 11673877 2038-03-27 U-3646 Drug product 2023-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208447-001 11673877 2038-03-27 U-3647 Drug product 2023-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 8071579 2027-08-12 U-2655 2019-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 8143241 2027-08-12 U-2655 2019-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 8436185 2029-04-24 Drug substance 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 8071623 2031-03-27 Drug substance, Drug product 2017-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 8859562 2031-08-04 U-2655 2019-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 11091459 2038-03-27 Drug product 2021-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208447-001 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 N208447-001 11673877 2038-03-27 U-3647 Drug product 2023-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208447-001 8071579 2027-08-12 U-2655 2019-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 8143241 2027-08-12 U-2655 2019-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 8436185 2029-04-24 Drug substance 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 8071623 2031-03-27 Drug substance, Drug product 2017-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 8859562 2031-08-04 U-2655 2019-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 11091459 2038-03-27 Drug product 2021-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 11673877 2038-03-27 U-3646 Drug product 2023-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208447-001 11673877 2038-03-27 U-3647 Drug product 2023-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 8071579 2027-08-12 U-2655 2019-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 8143241 2027-08-12 U-2655 2019-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 8436185 2029-04-24 Drug substance 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 8071623 2031-03-27 Drug substance, Drug product 2017-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 8859562 2031-08-04 U-2655 2019-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 11091459 2038-03-27 Drug product 2021-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 11673877 2038-03-27 U-3646 Drug product 2023-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208447-001 11673877 2038-03-27 U-3647 Drug product 2023-07-11 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 197 observed states.
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 Name fallback brand name: ZEJULA
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib TESARO, Inc. NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib TESARO, Inc. NDA Current 69656-103 ZEJULA niraparib GlaxoSmithKline LLC NDA Current 69656-103 ZEJULA niraparib TESARO, Inc. NDA Current