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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208447
Company: GLAXOSMITHKLINE

Products on NDA 208447

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208447

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208447Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208447_zejula_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-27	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208447s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208447Orig1s027ltr.pdf
09/14/2022	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208447s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208447Orig1s026ltr.pdf
12/08/2022	SUPPL-25	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208447s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208447Orig1s025ltr.pdf
07/27/2021	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208447Orig1s022,s024ltr.pdf
07/27/2021	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208447Orig1s022,s024ltr.pdf
03/03/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208447Orig1s019, s020ltr.pdf
03/03/2021	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208447Orig1s019, s020ltr.pdf
05/29/2020	SUPPL-18	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s018ltr.pdf
04/29/2020	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s015, s017ltr.pdf
04/29/2020	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s015, s017ltr.pdf
10/23/2019	SUPPL-14	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208447Orig1s014ltr.pdf
02/26/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208447Orig1s012ltr.pdf

Labels for NDA 208447

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-27	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208447s027lbl.pdf
12/08/2022	SUPPL-25	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208447s025lbl.pdf
09/14/2022	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208447s026lbl.pdf
07/27/2021	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s022s024lbl.pdf
07/27/2021	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s022s024lbl.pdf
03/03/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf
03/03/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf
03/03/2021	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf
04/29/2020	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbledt.pdf
04/29/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s015s017lbl.pdf
02/26/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208447s012lbl.pdf
10/23/2019	SUPPL-14	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208447s014lbl.pdf
03/27/2017	ORIG-1	Approval	Label (PDF)		httpS://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208447lbl.pdf

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