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FDA ANDA · ANDA074827
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Sponsor: COSETTE PHARMS NC
APPLICATION
ANDA074827
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 15MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 15MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 19 · standardAP
2009-10-30Labeling · Supplement 17AP
2006-11-29Labeling · Supplement 14AP
2001-08-30Manufacturing (CMC) · Supplement 4AP
2000-07-07Manufacturing (CMC) · Supplement 2AP
2000-05-15Labeling · Supplement 3AP
1999-03-22Manufacturing (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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