APPLICATION
ANDA074505
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-13
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPTOPRILPrescription
CAPTOPRIL 100MG · TABLET · ORAL
CAPTOPRILPrescription
CAPTOPRIL 25MG · TABLET · ORAL
CAPTOPRILPrescription
CAPTOPRIL 50MG · TABLET · ORAL
CAPTOPRILPrescription
CAPTOPRIL 12.5MG · TABLET · ORAL
Approval history
2020-03-03Labeling · Supplement 31 · standardAP
2016-02-23Labeling · Supplement 28 · standardAP
2016-02-23Labeling · Supplement 30 · standardAP
2014-12-05Labeling · Supplement 27 · standardAP
2014-11-03Labeling · Supplement 23 · standardAP
2014-11-03Labeling · Supplement 22AP
2011-07-22Labeling · Supplement 21AP
2001-08-10Manufacturing (CMC) · Supplement 11AP
2000-10-25Manufacturing (CMC) · Supplement 6AP
2000-10-25Manufacturing (CMC) · Supplement 10AP
2000-10-25Labeling · Supplement 7AP
2000-06-12Manufacturing (CMC) · Supplement 9AP
1999-08-27Labeling · Supplement 8AP
1998-10-01Manufacturing (CMC) · Supplement 5AP
1998-01-21Labeling · Supplement 4AP
1997-01-31Labeling · Supplement 3AP
1997-01-31Manufacturing (CMC) · Supplement 1AP
1997-01-31Manufacturing (CMC) · 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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