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FDA ANDA · ANDA087908

HYDRALAZINE HYDROCHLORIDE

Sponsor: VANGARD

APPLICATION
ANDA087908
TYPE
ANDA
ORIGINAL APPROVAL
1982-05-07
LATEST ACTION
1987-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

1987-10-20Manufacturing (CMC) · Supplement 9AP
1983-10-26Manufacturing (CMC) · Supplement 4AP
1983-10-26Manufacturing (CMC) · Supplement 5AP
1983-07-06Manufacturing (CMC) · Supplement 2AP
1982-05-07OriginalAP
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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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