APPLICATION
ANDA076273
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-14
LATEST ACTION
2023-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
Approval history
2023-01-09Labeling · Supplement 33 · standardAP
2021-12-21Labeling · Supplement 29 · standardAP
2019-08-20Labeling · Supplement 18 · standardAP
2019-08-02Labeling · Supplement 25 · standardAP
2019-08-02Labeling · Supplement 23 · standardAP
2019-08-02Labeling · Supplement 21 · standardAP
2019-08-02Labeling · Supplement 24 · standardAP
2019-08-02Labeling · Supplement 20 · standardAP
2016-05-11Labeling · Supplement 15 · standardAP
2016-05-11Labeling · Supplement 16 · standardAP
2016-05-11Labeling · Supplement 14 · standardAP
2014-06-12Labeling · Supplement 11 · standardAP
2014-06-12Labeling · Supplement 12 · standardAP
2012-04-18Labeling · Supplement 7AP
2012-04-18Labeling · Supplement 5AP
2012-04-18Labeling · Supplement 8AP
2012-04-18REMS · Supplement 6AP
2012-04-18Labeling · Supplement 4AP
2010-05-18Labeling · Supplement 3AP
2010-05-18Labeling · Supplement 2AP
2008-01-14OriginalAP
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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