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FDA ANDA · ANDA088356

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25

Sponsor: IVAX PHARMS

APPLICATION
ANDA088356
TYPE
ANDA
ORIGINAL APPROVAL
1984-04-10
LATEST ACTION
1984-04-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25Discontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 25MG · CAPSULE · ORAL

Approval history

1984-04-10OriginalAP
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