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FDA ANDA · ANDA087709

RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE

Sponsor: LEDERLE

APPLICATION
ANDA087709
TYPE
ANDA
LATEST ACTION
1983-09-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1983-09-07Manufacturing (CMC) · Supplement 3AP
1983-09-07Manufacturing (CMC) · Supplement 1AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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