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FDA ANDA · ANDA074788
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA074788
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-29
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 15MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 15MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 3 · standardAP
2002-07-18Manufacturing (CMC) · Supplement 2AP
1998-06-08Manufacturing (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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