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FDA ANDA · ANDA213351

CLOPIDOGREL

Sponsor: PURACAP LABS BLU

APPLICATION
ANDA213351
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-17
LATEST ACTION
2022-07-27
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

2022-07-27Labeling · Supplement 1 · standardAP
2020-07-17UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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