APPLICATION
ANDA070075
TYPE
ANDA
ORIGINAL APPROVAL
1985-04-18
LATEST ACTION
2004-08-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHYLDOPAPrescription
METHYLDOPA 250MG · TABLET · ORAL
Approval history
2004-08-04Labeling · Supplement 32AP
2000-01-19Manufacturing (CMC) · Supplement 29AP
1999-06-25Labeling · Supplement 30AP
1999-03-22Manufacturing (CMC) · Supplement 28AP
1998-08-25Labeling · Supplement 27AP
1998-07-30Manufacturing (CMC) · Supplement 26AP
1998-02-25Manufacturing (CMC) · Supplement 25AP
1998-02-05Manufacturing (CMC) · Supplement 24AP
1996-05-20Labeling · Supplement 23AP
1993-10-29Manufacturing (CMC) · Supplement 22AP
1993-03-19Labeling · Supplement 20AP
1992-07-16Manufacturing (CMC) · Supplement 18AP
1992-07-16Labeling · Supplement 16AP
1992-07-16Manufacturing (CMC) · Supplement 19AP
1992-07-16Manufacturing (CMC) · Supplement 17AP
1992-07-16Manufacturing (CMC) · Supplement 15AP
1990-12-17Labeling · Supplement 14AP
1990-01-31Manufacturing (CMC) · Supplement 13AP
1989-05-05Labeling · Supplement 11AP
1988-07-01Manufacturing (CMC) · Supplement 9AP
1988-07-01Manufacturing (CMC) · Supplement 5AP
1986-07-09Manufacturing (CMC) · Supplement 4AP
1986-04-17Manufacturing (CMC) · Supplement 2AP
1986-01-22Manufacturing (CMC) · Supplement 3AP
1985-04-18OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.