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FDA ANDA · ANDA089200
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: SUPERPHARM
APPLICATION
ANDA089200
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-09
LATEST ACTION
1989-02-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 25MG · CAPSULE · ORAL
Approval history
1989-02-09Labeling · Supplement 3AP
1987-02-09OriginalAP
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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