APPLICATION
ANDA070959
TYPE
ANDA
ORIGINAL APPROVAL
1989-01-19
LATEST ACTION
1998-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, METHYLDOPA 250MG · TABLET · ORAL
Approval history
1998-08-26Labeling · Supplement 11AP
1996-10-08Labeling · Supplement 10AP
1993-08-11Labeling · Supplement 9AP
1993-05-06Labeling · Supplement 8AP
1991-08-07Manufacturing (CMC) · Supplement 4AP
1991-05-24Labeling · Supplement 7AP
1991-04-29Manufacturing (CMC) · Supplement 2AP
1991-03-19Labeling · Supplement 6AP
1991-01-28Manufacturing (CMC) · Supplement 5AP
1989-08-17Labeling · Supplement 3AP
1989-05-09Labeling · Supplement 1AP
1989-01-19OriginalAP
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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