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FDA ANDA · ANDA090527

HYDRALAZINE HYDROCHLORIDE

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA090527
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-29
LATEST ACTION
2010-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2010-10-25Labeling · Supplement 1AP
2009-05-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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