APPLICATION
ANDA077665
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-17
LATEST ACTION
2025-09-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLOPIDOGREL BISULFATEDiscontinued
CLOPIDOGREL BISULFATE EQ 300MG BASE · TABLET · ORAL
CLOPIDOGREL BISULFATEDiscontinued
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
Approval history
2025-09-11Labeling · Supplement 15 · standardAP
2022-08-15Labeling · Supplement 13 · standardAP
2019-10-01Labeling · Supplement 12 · standardAP
2019-06-26Labeling · Supplement 10 · standardAP
2019-06-26Labeling · Supplement 8 · standardAP
2019-06-26Labeling · Supplement 11 · standardAP
2019-06-26Labeling · Supplement 9 · standardAP
2019-04-11Labeling · Supplement 7 · standardAP
2016-02-29Labeling · Supplement 6 · standardAP
2016-02-29Labeling · Supplement 2 · standardAP
2016-02-29Labeling · Supplement 5 · standardAP
2016-02-29Labeling · Supplement 3 · standardAP
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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