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FDA ANDA · ANDA083560

HYDRALAZINE HYDROCHLORIDE

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA083560
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 25MG · TABLET · ORAL

Approval history

2000-01-28Manufacturing (CMC) · Supplement 42AP
1987-05-27Manufacturing (CMC) · Supplement 40AP
1987-05-27Manufacturing (CMC) · Supplement 39AP
1985-08-15Manufacturing (CMC) · Supplement 12AP
1985-08-15Manufacturing (CMC) · Supplement 10AP
1985-08-15Manufacturing (CMC) · Supplement 4AP
1985-08-15Manufacturing (CMC) · Supplement 11AP
1985-05-06Manufacturing (CMC) · Supplement 37AP
1985-03-13Manufacturing (CMC) · Supplement 32AP
1985-03-13Manufacturing (CMC) · Supplement 29AP
1985-03-13Manufacturing (CMC) · Supplement 31AP
1976-08-05OriginalAP
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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