← FDA DRUG APPROVALS

FDA NDA · NDA208558

LYNPARZA

olaparib

Sponsor: ASTRAZENECA

APPLICATION
NDA208558
TYPE
NDA
ORIGINAL APPROVAL
2017-08-17
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LYNPARZA · ReferencePrescription
OLAPARIB 150MG · TABLET · ORAL
LYNPARZA · ReferencePrescription
OLAPARIB 100MG · TABLET · ORAL

Approval history

2025-07-10Labeling · Supplement 31 · standard — Letter ↗AP
2023-11-06Efficacy · Supplement 28 · standard — Letter ↗AP
2023-09-12Labeling · Supplement 29 · standard — Letter ↗AP
2023-05-31Efficacy · Supplement 25 · priority — Label ↗AP
2022-10-27Labeling · Supplement 24 · standard — Letter ↗AP
2022-08-26Efficacy · Supplement 26 · priority — Letter ↗AP
2022-03-11Efficacy · Supplement 23 · priority — Label ↗AP
2022-01-31Efficacy · Supplement 21 · standard — Letter ↗AP
2021-03-11Efficacy · Supplement 19 · standard — Letter ↗AP
2021-03-11Labeling · Supplement 20 · standard — Letter ↗AP
2020-12-07Efficacy · Supplement 16 · priority — Letter ↗AP
2020-11-02Labeling · Supplement 18 · standard — Label ↗AP
2020-05-19Efficacy · Supplement 14 · priority — Label ↗AP
2020-05-08Efficacy · Supplement 13 · priority — Label ↗AP
2019-12-27Efficacy · Supplement 10 · priority — Letter ↗AP
2019-10-11Labeling · Supplement 12 · standard — Letter ↗AP
2019-07-01Efficacy · Supplement 9 · standard — Letter ↗AP
2018-12-19Efficacy · Supplement 6 · priority — Label ↗AP
2018-09-26Efficacy · Supplement 5 · standard — Label ↗AP
2018-02-06Labeling · Supplement 2 · standard — Label ↗AP
2018-01-12Efficacy · Supplement 1 · priority — Label ↗AP
2017-08-17Type 3 - New Dosage Form · Original · priority — Label ↗AP
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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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