APPLICATION
ANDA202925
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-27
LATEST ACTION
2025-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CLOPIDOGREL BISULFATEDiscontinued
CLOPIDOGREL BISULFATE EQ 75MG BASE · TABLET · ORAL
CLOPIDOGREL BISULFATEDiscontinued
CLOPIDOGREL BISULFATE EQ 300MG BASE · TABLET · ORAL
Approval history
2025-02-11Labeling · Supplement 19 · standardAP
2023-08-29Labeling · Supplement 17 · standardAP
2023-08-29Labeling · Supplement 15 · standardAP
2019-09-20Labeling · Supplement 11 · standardAP
2019-07-19Labeling · Supplement 8 · standardAP
2019-07-19Labeling · Supplement 10 · standardAP
2019-07-19Labeling · Supplement 9 · standardAP
2019-07-19Labeling · Supplement 7 · standardAP
2015-11-05Labeling · Supplement 4 · standardAP
2015-11-05Labeling · Supplement 2 · standardAP
2015-11-05Labeling · Supplement 5 · standardAP
2015-11-05Labeling · Supplement 3 · standardAP
2013-03-27UNKNOWN · OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.