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FDA ANDA · ANDA084503

HYDRALAZINE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA084503
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-23
LATEST ACTION
1996-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

1996-07-02Manufacturing (CMC) · Supplement 37AP
1991-08-07Manufacturing (CMC) · Supplement 35AP
1990-11-19Manufacturing (CMC) · Supplement 36AP
1989-05-08Manufacturing (CMC) · Supplement 32AP
1989-05-08Manufacturing (CMC) · Supplement 30AP
1989-05-08Manufacturing (CMC) · Supplement 33AP
1989-05-08Manufacturing (CMC) · Supplement 31AP
1985-05-03Manufacturing (CMC) · Supplement 25AP
1984-04-24Manufacturing (CMC) · Supplement 22AP
1984-04-24Manufacturing (CMC) · Supplement 20AP
1984-04-24Manufacturing (CMC) · Supplement 19AP
1984-04-24Manufacturing (CMC) · Supplement 23AP
1982-06-16Manufacturing (CMC) · Supplement 16AP
1976-11-23OriginalAP
VIEW ON DRUGS@FDA ↗

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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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