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FDA ANDA · ANDA071822

METHYLDOPA AND HYDROCHLOROTHIAZIDE

Sponsor: TEVA

APPLICATION
ANDA071822
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-08
LATEST ACTION
1995-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG, METHYLDOPA 500MG · TABLET · ORAL

Approval history

1995-12-07Labeling · Supplement 2AP
1995-12-07Labeling · Supplement 9AP
1991-09-19Labeling · Supplement 7AP
1990-10-03Labeling · Supplement 6AP
1988-04-08OriginalAP
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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