APPLICATION
ANDA203751
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-11
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
Approval history
2025-08-01Labeling · Supplement 10 · standardAP
2025-08-01Labeling · Supplement 9 · standardAP
2022-05-05Labeling · Supplement 8 · standardAP
2022-05-05Labeling · Supplement 7 · standardAP
2019-09-12Labeling · Supplement 4 · standardAP
2019-09-12Labeling · Supplement 2 · standardAP
2019-09-12Labeling · Supplement 5 · standardAP
2019-09-12Labeling · Supplement 3 · standardAP
2014-04-11UNKNOWN · OriginalAP
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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