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FDA ANDA · ANDA076608

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA076608
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-03
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-08-20Labeling · Supplement 6 · standardAP
2020-07-23Labeling · Supplement 5 · standardAP
2004-12-03Original — Letter ↗AP
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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