APPLICATION
ANDA070085
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-15
LATEST ACTION
2011-09-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPADiscontinued
METHYLDOPA 500MG · TABLET · ORAL
Approval history
2011-09-21Labeling · Supplement 29AP
1999-09-10Labeling · Supplement 28AP
1999-07-12Manufacturing (CMC) · Supplement 27AP
1999-03-19Manufacturing (CMC) · Supplement 26AP
1998-06-11Labeling · Supplement 25AP
1997-02-18Labeling · Supplement 24AP
1995-08-31Manufacturing (CMC) · Supplement 22AP
1995-08-31Manufacturing (CMC) · Supplement 23AP
1993-04-30Labeling · Supplement 21AP
1992-08-31Manufacturing (CMC) · Supplement 20AP
1991-03-20Labeling · Supplement 19AP
1990-12-12Labeling · Supplement 18AP
1990-11-21Manufacturing (CMC) · Supplement 14AP
1990-11-21Manufacturing (CMC) · Supplement 15AP
1989-08-14Bioequivalence · Supplement 16AP
1988-09-07Labeling · Supplement 8AP
1988-08-02Labeling · Supplement 12AP
1988-01-28Manufacturing (CMC) · Supplement 9AP
1988-01-28Manufacturing (CMC) · Supplement 11AP
1987-10-13Manufacturing (CMC) · Supplement 6AP
1987-10-13Manufacturing (CMC) · Supplement 7AP
1987-01-09Manufacturing (CMC) · Supplement 4AP
1987-01-09Manufacturing (CMC) · Supplement 2AP
1985-10-15OriginalAP
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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