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FDA ANDA · ANDA075055
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Sponsor: IVAX SUB TEVA PHARMS
APPLICATION
ANDA075055
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-18
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
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
CAPTOPRIL AND HYDROCHLOROTHIAZIDEDiscontinued
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2002-07-29Manufacturing (CMC) · Supplement 10AP
2002-03-12Manufacturing (CMC) · Supplement 9AP
2001-11-07Manufacturing (CMC) · Supplement 7AP
2001-04-13Manufacturing (CMC) · Supplement 5AP
2001-04-13Manufacturing (CMC) · Supplement 6AP
2001-04-13Manufacturing (CMC) · Supplement 4AP
2000-03-28Manufacturing (CMC) · Supplement 3AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1999-07-23Manufacturing (CMC) · Supplement 1AP
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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