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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214876
Company: GLAXOSMITHKLINE

Products on NDA 214876

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEJULA	NIRAPARIB TOSYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ZEJULA	NIRAPARIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	None	Yes	No
ZEJULA	NIRAPARIB TOSYLATE	EQ 300MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214876

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2023	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214876Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214876Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2026	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214876Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214876Orig1s006ltr.pdf
07/18/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214876Orig1s005ltr.pdf
06/18/2025	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214876Orig1s003,s004ltr.pdf
06/18/2025	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214876Orig1s003,s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/214876Orig1s003Med,StatR.pdf

Labels for NDA 214876

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2026	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214876Orig1s006lbl.pdf
03/27/2026	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214876Orig1s006lbl.pdf
07/18/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876Orig1s005lbl.pdf
06/18/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf
06/18/2025	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf
04/26/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf

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