APPLICATION
ANDA087407
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-11
LATEST ACTION
1998-12-01
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ERGOLOID MESYLATESDiscontinued
ERGOLOID MESYLATES 0.5MG · TABLET · SUBLINGUAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 20AP
1994-12-23Manufacturing (CMC) · Supplement 19AP
1994-10-11Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1992-04-03Manufacturing (CMC) · Supplement 15AP
1989-04-10Labeling · Supplement 13AP
1988-12-23Labeling · Supplement 14AP
1987-03-31Manufacturing (CMC) · Supplement 11AP
1984-07-26Manufacturing (CMC) · Supplement 5AP
1984-07-26Manufacturing (CMC) · Supplement 6AP
1983-11-03Manufacturing (CMC) · Supplement 4AP
1981-08-11OriginalAP
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.