APPLICATION
ANDA072128
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-07
LATEST ACTION
1998-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLDOPADiscontinued
METHYLDOPA 500MG · TABLET · ORAL
Approval history
1998-06-12Labeling · Supplement 11AP
1996-06-10Labeling · Supplement 10AP
1994-05-11Manufacturing (CMC) · Supplement 9AP
1993-05-05Labeling · Supplement 8AP
1993-05-05Manufacturing (CMC) · Supplement 6AP
1993-05-05Manufacturing (CMC) · Supplement 7AP
1993-05-05Manufacturing (CMC) · Supplement 5AP
1992-04-22Labeling · Supplement 4AP
1990-12-18Labeling · Supplement 3AP
1989-06-26Manufacturing (CMC) · Supplement 2AP
1988-07-07OriginalAP
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.