APPLICATION
ANDA070265
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-23
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, METHYLDOPA 250MG · TABLET · ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 15MG, METHYLDOPA 250MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 47 · standardAP
2005-12-12Labeling · Supplement 28AP
2001-09-05Manufacturing (CMC) · Supplement 25AP
2000-05-02Manufacturing (CMC) · Supplement 24AP
2000-01-24Manufacturing (CMC) · Supplement 22AP
1999-11-24Labeling · Supplement 23AP
1998-06-16Labeling · Supplement 21AP
1998-02-25Manufacturing (CMC) · Supplement 20AP
1997-10-27Manufacturing (CMC) · Supplement 19AP
1996-06-20Manufacturing (CMC) · Supplement 17AP
1996-06-20Manufacturing (CMC) · Supplement 15AP
1996-06-20Manufacturing (CMC) · Supplement 18AP
1996-06-20Labeling · Supplement 16AP
1995-06-20Manufacturing (CMC) · Supplement 14AP
1993-10-22Manufacturing (CMC) · Supplement 13AP
1993-04-29Labeling · Supplement 11AP
1991-09-26Labeling · Supplement 10AP
1991-06-20Labeling · Supplement 9AP
1991-01-25Manufacturing (CMC) · Supplement 6AP
1991-01-25Manufacturing (CMC) · Supplement 5AP
1990-01-31Manufacturing (CMC) · Supplement 8AP
1989-11-20Labeling · Supplement 7AP
1986-08-07Manufacturing (CMC) · Supplement 2AP
1986-01-23OriginalAP
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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