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FDA ANDA · ANDA087556

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Sponsor: WATSON LABS

APPLICATION
ANDA087556
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-06
LATEST ACTION
1988-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 15MG, RESERPINE 0.1MG · TABLET · ORAL

Approval history

1988-05-11Labeling · Supplement 7AP
1981-08-06OriginalAP
VIEW ON DRUGS@FDA ↗

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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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