APPLICATION
ANDA088391
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-27
LATEST ACTION
2001-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRALAZINE HYDROCHLORIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2001-12-11Labeling · Supplement 11AP
1988-11-04Labeling · Supplement 10AP
1988-07-14Labeling · Supplement 9AP
1986-05-15Manufacturing (CMC) · Supplement 2AP
1983-09-27OriginalAP
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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