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FDA ANDA · ANDA090255

HYDRALAZINE HYDROCHLORIDE

Sponsor: INVAGEN PHARMS

APPLICATION
ANDA090255
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-15
LATEST ACTION
2008-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 50MG · TABLET · ORAL
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

2008-12-15OriginalAP
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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