← FDA DRUG APPROVALS

FDA ANDA · ANDA204359

CLOPIDOGREL BISULFATE

Sponsor: RISING

APPLICATION
ANDA204359
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-02
LATEST ACTION
2019-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL

Approval history

2019-05-28Labeling · Supplement 4 · standardAP
2019-05-28Manufacturing (CMC) · Supplement 7 · unknownAP
2019-05-28Labeling · Supplement 5 · standardAP
2019-05-28Labeling · Supplement 3 · standardAP
2019-05-28Labeling · Supplement 8 · standardAP
2018-10-29Manufacturing (CMC) · Supplement 6 · unknownAP
2017-02-02UNKNOWN · OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →