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FDA NDA · NDA208447

ZEJULA

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA208447
TYPE
NDA
ORIGINAL APPROVAL
2017-03-27
LATEST ACTION
2023-04-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZEJULA · ReferenceDiscontinued
NIRAPARIB TOSYLATE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2023-04-26Efficacy · Supplement 27 · standard — Label ↗AP
2022-12-08Efficacy · Supplement 25 · standard — Letter ↗AP
2022-09-14Labeling · Supplement 26 · standard — Label ↗AP
2021-07-27Labeling · Supplement 24 · standard — Letter ↗AP
2021-07-27Labeling · Supplement 22 · standard — Letter ↗AP
2021-03-03Labeling · Supplement 19 · standard — Label ↗AP
2021-03-03Labeling · Supplement 20 · standard — Label ↗AP
2020-05-29Labeling · Supplement 18 · standard — Letter ↗AP
2020-04-29Efficacy · Supplement 17 · priority — Label ↗AP
2020-04-29Labeling · Supplement 15 · standard — Label ↗AP
2020-02-26Labeling · Supplement 12 · standard — Label ↗AP
2019-10-23Efficacy · Supplement 14 · priority — Label ↗AP
2017-03-27Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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