APPLICATION
ANDA088729
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-11
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 13AP
1994-12-23Manufacturing (CMC) · Supplement 12AP
1994-10-11Manufacturing (CMC) · Supplement 11AP
1992-04-03Manufacturing (CMC) · Supplement 8AP
1992-04-03Manufacturing (CMC) · Supplement 10AP
1987-03-31Manufacturing (CMC) · Supplement 5AP
1985-08-09Manufacturing (CMC) · Supplement 1AP
1985-04-11OriginalAP
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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