APPLICATION
ANDA072507
TYPE
ANDA
ORIGINAL APPROVAL
1989-06-02
LATEST ACTION
1999-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 15MG, METHYLDOPA 250MG · TABLET · ORAL
Approval history
1999-02-17Manufacturing (CMC) · Supplement 9AP
1998-04-14Labeling · Supplement 8AP
1997-06-23Labeling · Supplement 7AP
1996-02-12Manufacturing (CMC) · Supplement 5AP
1996-02-12Manufacturing (CMC) · Supplement 6AP
1995-01-13Labeling · Supplement 4AP
1993-04-14Labeling · Supplement 3AP
1992-04-02Labeling · Supplement 2AP
1991-03-06Manufacturing (CMC) · Supplement 1AP
1989-06-02OriginalAP
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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