Zejula

NDA 208447, held by Glaxosmithkline. Niraparib Tosylate.

As of Nov 13, 2026, NDA 208447 (Zejula), held by Glaxosmithkline, was first approved by FDA on Mar 27, 2017, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 27, 2017
Review: Priority
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Apr 26, 2023	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 8, 2022	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 29, 2020	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 23, 2019	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 27, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
ZejulaEQ 100MG BASE · capsule;oral	Niraparib Tosylate	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 26, 2023	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 8, 2022	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 14, 2022	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 27, 2021	Supplement 24Labeling · Standard review	Approved	Letter Label
Jul 27, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
Mar 3, 2021	Supplement 20Labeling · Standard review	Approved	Label Letter
Mar 3, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
May 29, 2020	Supplement 18Labeling · Standard review	Approved	Letter
Apr 29, 2020	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 29, 2020	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 26, 2020	Supplement 12Labeling · Standard review	Approved	Label Letter
Oct 23, 2019	Supplement 14Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 27, 2017	Original applicationNew molecular entity · Priority review	Approved	Review Letter

Identifiers

Application: NDA 208447
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters