← FDA DRUG APPROVALS

FDA ANDA · ANDA083561

HYDRALAZINE HYDROCHLORIDE

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA083561
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-05
LATEST ACTION
2000-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2000-01-28Manufacturing (CMC) · Supplement 27AP
1986-10-17Manufacturing (CMC) · Supplement 24AP
1986-08-06Manufacturing (CMC) · Supplement 25AP
1985-08-21Manufacturing (CMC) · Supplement 9AP
1985-08-21Manufacturing (CMC) · Supplement 3AP
1985-08-21Manufacturing (CMC) · Supplement 8AP
1985-08-21Manufacturing (CMC) · Supplement 10AP
1985-05-06Manufacturing (CMC) · Supplement 23AP
1985-03-15Manufacturing (CMC) · Supplement 21AP
1985-03-15Manufacturing (CMC) · Supplement 20AP
1976-08-05OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →