← FDA DRUG APPROVALS

FDA ANDA · ANDA087233

ERGOLOID MESYLATES

Sponsor: WATSON LABS

APPLICATION
ANDA087233
TYPE
ANDA
ORIGINAL APPROVAL
1981-04-16
LATEST ACTION
1991-05-31
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ERGOLOID MESYLATESDiscontinued
ERGOLOID MESYLATES 0.5MG · TABLET · SUBLINGUAL

Approval history

1991-05-31Manufacturing (CMC) · Supplement 13AP
1990-11-19Manufacturing (CMC) · Supplement 14AP
1990-06-29Manufacturing (CMC) · Supplement 12AP
1989-02-07Labeling · Supplement 11AP
1988-12-06Labeling · Supplement 8AP
1988-08-05Manufacturing (CMC) · Supplement 9AP
1985-07-09Manufacturing (CMC) · Supplement 6AP
1981-04-16OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →