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FDA NDA · NDA209115

RUBRACA

rucaparib

Sponsor: PHARMAAND

APPLICATION
NDA209115
TYPE
NDA
ORIGINAL APPROVAL
2016-12-19
LATEST ACTION
2025-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RUBRACA · ReferencePrescription
RUCAPARIB CAMSYLATE EQ 250MG BASE · TABLET · ORAL
RUBRACA · ReferencePrescription
RUCAPARIB CAMSYLATE EQ 200MG BASE · TABLET · ORAL
RUBRACA · ReferencePrescription
RUCAPARIB CAMSYLATE EQ 300MG BASE · TABLET · ORAL

Approval history

2025-12-17Efficacy · Supplement 15 · standard — Letter ↗AP
2025-12-17Efficacy · Supplement 14 · standard — Letter ↗AP
2022-12-21Efficacy · Supplement 13 · priority — Letter ↗AP
2022-06-10Efficacy · Supplement 11 · priority — Label ↗AP
2021-09-30Labeling · Supplement 9 · standard — Label ↗AP
2020-10-08Efficacy · Supplement 8 · priority — Letter ↗AP
2020-05-15Efficacy · Supplement 4 · priority — Label ↗AP
2018-04-06Efficacy · Supplement 3 · priority — Label ↗AP
2016-12-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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