← FDA DRUG APPROVALS

FDA NDA · NDA022307

EFFIENT

prasugrel hydrochloride

Sponsor: COSETTE

APPLICATION
NDA022307
TYPE
NDA
ORIGINAL APPROVAL
2009-07-10
LATEST ACTION
2020-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EFFIENT · ReferencePrescription
PRASUGREL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
EFFIENT · ReferencePrescription
PRASUGREL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL

Approval history

2020-12-22Labeling · Supplement 18 · standard — Letter ↗AP
2019-03-28Labeling · Supplement 16 · standard — Letter ↗AP
2018-03-09Labeling · Supplement 15 · standard — Label ↗AP
2016-07-12Efficacy · Supplement 14 · priority — Label ↗AP
2016-01-14Labeling · Supplement 13 · standard — Letter ↗AP
2015-07-07Labeling · Supplement 12 · standard — Label ↗AP
2013-11-19Labeling · Supplement 10 · standard — Letter ↗AP
2013-10-16Efficacy · Supplement 8 · standard — Label ↗AP
2012-11-30Labeling · Supplement 7 · unknown — Label ↗AP
2012-03-23REMS · Supplement 6 — Letter ↗AP
2011-09-27Labeling · Supplement 3 · unknown — Label ↗AP
2010-12-06Labeling · Supplement 2 · unknown — Letter ↗AP
2010-04-16Manufacturing (CMC) · Supplement 1 · priority — Label ↗AP
2009-07-10Type 1 - New Molecular Entity · Original · priority — Review ↗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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