APPLICATION
ANDA091023
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-17
LATEST ACTION
2023-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 300MG BASE · TABLET · ORAL
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
Approval history
2023-05-08Labeling · Supplement 20 · standardAP
2022-09-16Labeling · Supplement 17 · standardAP
2019-08-07Labeling · Supplement 10 · standardAP
2019-08-07Labeling · Supplement 8 · standardAP
2019-08-07Labeling · Supplement 13 · standardAP
2019-08-07Labeling · Supplement 11 · standardAP
2019-08-07Labeling · Supplement 9 · standardAP
2019-08-07Labeling · Supplement 14 · standardAP
2016-05-11Labeling · Supplement 7 · standardAP
2015-07-28Manufacturing (CMC) · Supplement 4 · unknownAP
2015-04-17Labeling · Supplement 6 · standardAP
2015-04-17Labeling · Supplement 5 · standardAP
2015-04-17Labeling · Supplement 3 · standardAP
2013-04-04Labeling · Supplement 1 · 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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