APPLICATION
ANDA074434
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-13
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPTOPRILDiscontinued
CAPTOPRIL 50MG · TABLET · ORAL
CAPTOPRILDiscontinued
CAPTOPRIL 12.5MG · TABLET · ORAL
CAPTOPRILDiscontinued
CAPTOPRIL 100MG · TABLET · ORAL
CAPTOPRILDiscontinued
CAPTOPRIL 25MG · TABLET · ORAL
Approval history
2020-03-03Labeling · Supplement 16 · standardAP
2015-11-09Labeling · Supplement 15 · standardAP
2015-04-22Labeling · Supplement 13 · standardAP
2015-04-22Labeling · Supplement 14 · standardAP
2004-07-19Labeling · Supplement 7AP
2002-04-22Manufacturing (CMC) · Supplement 6AP
2001-11-13Manufacturing (CMC) · Supplement 5AP
1999-12-13Labeling · Supplement 4AP
1998-02-27Labeling · Supplement 3AP
1997-10-30Manufacturing (CMC) · Supplement 1AP
1997-10-14Labeling · Supplement 2AP
1996-02-13OriginalAP
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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