APPLICATION
ANDA074483
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-13
LATEST ACTION
2002-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPTOPRILDiscontinued
CAPTOPRIL 100MG · TABLET · ORAL
CAPTOPRILDiscontinued
CAPTOPRIL 25MG · TABLET · ORAL
CAPTOPRILDiscontinued
CAPTOPRIL 50MG · TABLET · ORAL
CAPTOPRILDiscontinued
CAPTOPRIL 12.5MG · TABLET · ORAL
Approval history
2002-02-26Manufacturing (CMC) · Supplement 14AP
2001-08-30Manufacturing (CMC) · Supplement 13AP
2000-07-07Manufacturing (CMC) · Supplement 11AP
2000-04-11Labeling · Supplement 12AP
2000-02-22Manufacturing (CMC) · Supplement 10AP
1999-07-12Manufacturing (CMC) · Supplement 9AP
1998-01-07Manufacturing (CMC) · Supplement 7AP
1997-10-01Labeling · Supplement 8AP
1997-04-10Manufacturing (CMC) · Supplement 5AP
1997-01-28Labeling · Supplement 6AP
1996-12-13Manufacturing (CMC) · Supplement 4AP
1996-08-13Manufacturing (CMC) · Supplement 2AP
1996-08-13Manufacturing (CMC) · Supplement 3AP
1996-08-13Manufacturing (CMC) · Supplement 1AP
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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