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FDA ANDA · ANDA084810

APRESAZIDE

Sponsor: NOVARTIS

APPLICATION
ANDA084810
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 50MG, HYDROCHLOROTHIAZIDE 50MG · CAPSULE · ORAL

Approval history

1999-07-20Manufacturing (CMC) · Supplement 31AP
1998-11-20Manufacturing (CMC) · Supplement 30AP
1996-12-02Manufacturing (CMC) · Supplement 29AP
1996-01-30Labeling · Supplement 28AP
1993-04-07Labeling · Supplement 27AP
1992-11-04Labeling · Supplement 26AP
1992-06-18Manufacturing (CMC) · Supplement 24AP
1992-02-21Labeling · Supplement 25AP
1991-06-20Labeling · Supplement 23AP
1989-03-06Labeling · Supplement 19AP
1988-11-22Manufacturing (CMC) · Supplement 17AP
1988-11-22Manufacturing (CMC) · Supplement 15AP
1988-11-22Manufacturing (CMC) · Supplement 18AP
1988-11-22Manufacturing (CMC) · Supplement 16AP
1982-03-23Manufacturing (CMC) · Supplement 11AP
1982-03-23Manufacturing (CMC) · Supplement 8AP
1982-03-23Manufacturing (CMC) · Supplement 10AP
1976-05-26OriginalAP
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