APPLICATION
ANDA070343
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-20
LATEST ACTION
2011-08-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPADiscontinued
METHYLDOPA 500MG · TABLET · ORAL
Approval history
2011-08-17Labeling · Supplement 58AP
2005-07-26Labeling · Supplement 52AP
2002-07-29Manufacturing (CMC) · Supplement 46AP
2001-09-12Manufacturing (CMC) · Supplement 44AP
2000-07-26Manufacturing (CMC) · Supplement 38AP
2000-07-26Manufacturing (CMC) · Supplement 40AP
2000-07-26Manufacturing (CMC) · Supplement 39AP
2000-07-26Manufacturing (CMC) · Supplement 43AP
2000-03-28Manufacturing (CMC) · Supplement 36AP
2000-03-22Labeling · Supplement 42AP
2000-03-22Manufacturing (CMC) · Supplement 35AP
2000-03-22Manufacturing (CMC) · Supplement 41AP
2000-01-28Manufacturing (CMC) · Supplement 34AP
2000-01-18Labeling · Supplement 37AP
1999-11-23Manufacturing (CMC) · Supplement 33AP
1999-08-20Manufacturing (CMC) · Supplement 32AP
1999-07-20Manufacturing (CMC) · Supplement 30AP
1999-01-28Labeling · Supplement 31AP
1998-12-09Manufacturing (CMC) · Supplement 29AP
1997-05-30Manufacturing (CMC) · Supplement 28AP
1997-01-06Manufacturing (CMC) · Supplement 26AP
1997-01-06Manufacturing (CMC) · Supplement 25AP
1996-12-10Labeling · Supplement 27AP
1996-03-13Manufacturing (CMC) · Supplement 24AP
1993-09-01Labeling · Supplement 23AP
1992-08-12Manufacturing (CMC) · Supplement 21AP
1992-08-12Manufacturing (CMC) · Supplement 22AP
1991-08-12Labeling · Supplement 20AP
1990-09-27Manufacturing (CMC) · Supplement 17AP
1990-09-27Manufacturing (CMC) · Supplement 18AP
1988-07-29Manufacturing (CMC) · Supplement 15AP
1988-07-29Manufacturing (CMC) · Supplement 14AP
1988-02-09Manufacturing (CMC) · Supplement 12AP
1988-01-12Manufacturing (CMC) · Supplement 8AP
1988-01-12Manufacturing (CMC) · Supplement 9AP
1988-01-12Manufacturing (CMC) · Supplement 10AP
1987-12-29Manufacturing (CMC) · Supplement 4AP
1987-12-29Manufacturing (CMC) · Supplement 5AP
1987-10-20Manufacturing (CMC) · Supplement 11AP
1987-04-20Manufacturing (CMC) · Supplement 3AP
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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