APPLICATION
ANDA074896
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-29
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CAPTOPRIL AND HYDROCHLOROTHIAZIDEPrescription
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 15MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEPrescription
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEPrescription
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEPrescription
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 15MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 31 · standardAP
2020-07-30Labeling · Supplement 30 · standardAP
2006-08-14Labeling · Supplement 7AP
2002-08-21Manufacturing (CMC) · Supplement 4AP
2001-09-05Manufacturing (CMC) · Supplement 3AP
2000-08-25Labeling · Supplement 2AP
2000-08-11Manufacturing (CMC) · Supplement 1AP
1997-12-29OriginalAP
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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