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FDA NDA · NDA206162

LYNPARZA

Sponsor: ASTRAZENECA

APPLICATION
NDA206162
TYPE
NDA
ORIGINAL APPROVAL
2014-12-19
LATEST ACTION
2018-09-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

LYNPARZA · ReferenceDiscontinued
OLAPARIB 50MG · CAPSULE · ORAL

Approval history

2018-09-27Labeling · Supplement 11 · standard — Letter ↗AP
2017-10-23Labeling · Supplement 8 · standard — Label ↗AP
2017-08-17Efficacy · Supplement 7 · priority — Letter ↗AP
2017-01-26Labeling · Supplement 3 · standard — Label ↗AP
2016-10-19Labeling · Supplement 2 · standard — Letter ↗AP
2016-01-12Manufacturing (CMC) · Supplement 1 · priorityAP
2014-12-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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