← FDA DRUG APPROVALS

FDA ANDA · ANDA076274

CLOPIDOGREL

clopidogrel bisulfate

Sponsor: APOTEX INC

APPLICATION
ANDA076274
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-17
LATEST ACTION
2023-09-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 300MG BASE · TABLET · ORAL

Approval history

2023-09-07Labeling · Supplement 28 · standardAP
2023-09-07Labeling · Supplement 27 · standardAP
2021-08-16Labeling · Supplement 26 · standardAP
2019-11-22Labeling · Supplement 18 · standardAP
2019-11-22Labeling · Supplement 16 · standardAP
2019-11-22Labeling · Supplement 14 · standardAP
2019-11-22Labeling · Supplement 20 · standardAP
2019-11-22Labeling · Supplement 10 · standardAP
2019-11-22Labeling · Supplement 17 · standardAP
2019-11-22Labeling · Supplement 23 · standardAP
2019-11-22Labeling · Supplement 11 · standardAP
2014-11-03Labeling · Supplement 5 · standardAP
2014-03-13Labeling · Supplement 4 · standardAP
2014-03-04OriginalAP
2012-05-17Original — Letter ↗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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