APPLICATION
ANDA070073
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-09
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPADiscontinued
METHYLDOPA 125MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 22AP
1998-08-05Labeling · Supplement 23AP
1996-10-11Labeling · Supplement 21AP
1994-12-23Manufacturing (CMC) · Supplement 20AP
1994-10-11Manufacturing (CMC) · Supplement 19AP
1993-04-21Labeling · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1992-04-03Manufacturing (CMC) · Supplement 15AP
1991-05-06Labeling · Supplement 14AP
1989-11-06Bioequivalence · Supplement 12AP
1989-04-25Labeling · Supplement 10AP
1989-01-25Labeling · Supplement 9AP
1989-01-11Manufacturing (CMC) · Supplement 8AP
1988-01-21Manufacturing (CMC) · Supplement 3AP
1988-01-21Manufacturing (CMC) · Supplement 1AP
1988-01-21Manufacturing (CMC) · Supplement 6AP
1988-01-21Manufacturing (CMC) · Supplement 2AP
1987-03-31Manufacturing (CMC) · Supplement 5AP
1986-10-09OriginalAP
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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