APPLICATION
ANDA084897
TYPE
ANDA
ORIGINAL APPROVAL
1979-11-20
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAM-AP-ESDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 15MG, RESERPINE 0.1MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 36 · standardAP
2000-10-06Manufacturing (CMC) · Supplement 35AP
1992-07-06Labeling · Supplement 30AP
1992-02-11Labeling · Supplement 29AP
1991-03-15Labeling · Supplement 28AP
1989-05-09Labeling · Supplement 27AP
1988-06-02Manufacturing (CMC) · Supplement 26AP
1988-03-30Manufacturing (CMC) · Supplement 25AP
1983-02-11Manufacturing (CMC) · Supplement 18AP
1979-11-20OriginalAP
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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