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FDA ANDA · ANDA203845

HYDRALAZINE

hydralazine hydrochloride

Sponsor: CADILA PHARMS LTD

APPLICATION
ANDA203845
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-18
LATEST ACTION
2018-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2018-10-30Labeling · Supplement 1 · standardAP
2018-10-30Manufacturing (CMC) · Supplement 2 · unknownAP
2014-09-18UNKNOWN · OriginalAP
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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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