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FDA ANDA · ANDA090540
CLOPIDOGREL
clopidogrel bisulfate
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA090540
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-17
LATEST ACTION
2023-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOPIDOGREL BISULFATEPrescription
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
Approval history
2023-06-08Labeling · Supplement 27 · standardAP
2023-06-08Labeling · Supplement 31 · standardAP
2019-09-20Labeling · Supplement 19 · standardAP
2019-04-03Labeling · Supplement 14 · standardAP
2019-04-03Labeling · Supplement 12 · standardAP
2019-04-03Labeling · Supplement 17 · standardAP
2019-04-03Labeling · Supplement 15 · standardAP
2019-04-03Labeling · Supplement 13 · standardAP
2016-05-11Labeling · Supplement 10 · standardAP
2016-05-11Labeling · Supplement 9 · standardAP
2014-06-11Labeling · Supplement 6 · standardAP
2014-06-11Labeling · Supplement 7 · 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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