APPLICATION
ANDA084735
TYPE
ANDA
ORIGINAL APPROVAL
1976-05-26
LATEST ACTION
1999-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
APRESAZIDE · ReferenceDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 25MG · CAPSULE · ORAL
Approval history
1999-07-20Manufacturing (CMC) · Supplement 37AP
1998-11-20Manufacturing (CMC) · Supplement 36AP
1996-12-02Manufacturing (CMC) · Supplement 35AP
1996-01-30Labeling · Supplement 34AP
1993-04-07Labeling · Supplement 33AP
1992-11-04Labeling · Supplement 32AP
1992-06-18Manufacturing (CMC) · Supplement 30AP
1992-04-30Manufacturing (CMC) · Supplement 22AP
1992-02-21Labeling · Supplement 31AP
1991-06-20Labeling · Supplement 29AP
1989-03-06Labeling · Supplement 23AP
1989-02-09Manufacturing (CMC) · Supplement 24AP
1988-11-22Manufacturing (CMC) · Supplement 21AP
1988-11-22Manufacturing (CMC) · Supplement 18AP
1988-11-22Manufacturing (CMC) · Supplement 20AP
1988-11-22Manufacturing (CMC) · Supplement 19AP
1988-11-03Labeling · Supplement 26AP
1983-09-16Manufacturing (CMC) · Supplement 14AP
1982-03-24Manufacturing (CMC) · Supplement 11AP
1982-03-24Manufacturing (CMC) · Supplement 12AP
1982-03-24Manufacturing (CMC) · Supplement 9AP
1976-05-26OriginalAP
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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