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FDA ANDA · ANDA079025

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA079025
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-17
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-08-20Labeling · Supplement 4 · standardAP
2014-01-03Labeling · Supplement 1 · standardAP
2010-09-17OriginalAP
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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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