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FDA ANDA · ANDA040858

HYDRALAZINE HYDROCHLORIDE

Sponsor: HERITAGE PHARMS INC

APPLICATION
ANDA040858
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-26
LATEST ACTION
2023-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-10-06Labeling · Supplement 2 · standardAP
2010-02-26OriginalAP
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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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