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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206162
Company: ASTRAZENECA

Medication Guide

Summary Review

Products on NDA 206162

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LYNPARZA	OLAPARIB	50MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206162

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206162Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206162Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206162Orig1s011ltr.pdf
10/23/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206162Orig1s008ltr.pdf
08/17/2017	SUPPL-7	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206162Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/206162Orig1s007.pdf
01/26/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206162Orig1s003ltr.pdf
10/19/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206162s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206162Orig1s002ltr.pdf
01/12/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206162

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206162s011lbl.pdf
10/23/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s008lbl.pdf
08/17/2017	SUPPL-7	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s007lbl.pdf
01/26/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206162s003lbl.pdf
10/19/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206162s002lbl.pdf
12/19/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf

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