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FDA ANDA · ANDA086962

HYDRALAZINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA086962
TYPE
ANDA
ORIGINAL APPROVAL
1980-02-27
LATEST ACTION
2001-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2001-12-11Labeling · Supplement 30AP
1988-11-04Labeling · Supplement 29AP
1988-07-14Labeling · Supplement 28AP
1986-05-07Manufacturing (CMC) · Supplement 23AP
1983-07-28Manufacturing (CMC) · Supplement 18AP
1983-07-28Manufacturing (CMC) · Supplement 19AP
1983-07-28Manufacturing (CMC) · Supplement 17AP
1983-07-28Manufacturing (CMC) · Supplement 21AP
1982-03-16Manufacturing (CMC) · Supplement 15AP
1980-02-27OriginalAP
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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