APPLICATION
ANDA089359
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-25
LATEST ACTION
2000-05-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2000-05-16Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 12AP
1997-12-05Manufacturing (CMC) · Supplement 10AP
1997-02-24Manufacturing (CMC) · Supplement 9AP
1996-09-16Labeling · Supplement 8AP
1996-03-25Labeling · Supplement 7AP
1995-06-22Manufacturing (CMC) · Supplement 6AP
1994-01-21Manufacturing (CMC) · Supplement 4AP
1994-01-12Manufacturing (CMC) · Supplement 5AP
1989-12-06Labeling · Supplement 3AP
1986-07-25OriginalAP
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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