APPLICATION
ANDA088961
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-21
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDRA-ZIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 100MG, HYDROCHLOROTHIAZIDE 50MG · CAPSULE · ORAL
Approval history
2020-08-20Labeling · Supplement 22 · standardAP
1997-11-26Manufacturing (CMC) · Supplement 18AP
1997-11-26Manufacturing (CMC) · Supplement 17AP
1995-02-03Labeling · Supplement 16AP
1991-06-14Labeling · Supplement 15AP
1991-04-04Labeling · Supplement 14AP
1989-05-08Labeling · Supplement 12AP
1989-01-26Labeling · Supplement 11AP
1988-11-29Labeling · Supplement 10AP
1988-11-29Labeling · Supplement 23AP
1988-05-02Manufacturing (CMC) · Supplement 7AP
1985-10-21OriginalAP
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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