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FDA ANDA · ANDA090228

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA090228
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-09
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2020-08-20Labeling · Supplement 9 · standardAP
2015-09-14Labeling · Supplement 2 · standardAP
2015-09-14Labeling · Supplement 3 · standardAP
2009-07-09OriginalAP
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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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