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FDA ANDA · ANDA076961

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Sponsor: SANDOZ

APPLICATION
ANDA076961
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-28
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEPrescription
FOSINOPRIL SODIUM 20MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEPrescription
FOSINOPRIL SODIUM 10MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL

Approval history

2020-08-20Labeling · Supplement 19 · standardAP
2014-01-03Labeling · Supplement 8AP
2014-01-03Labeling · Supplement 15 · standardAP
2011-08-31Labeling · Supplement 7AP
2005-09-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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