← FDA DRUG APPROVALS

FDA ANDA · ANDA083234

GLUTETHIMIDE

Sponsor: UPSHER SMITH LABS

APPLICATION
ANDA083234
TYPE
ANDA
ORIGINAL APPROVAL
1976-10-28
LATEST ACTION
2000-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GLUTETHIMIDEDiscontinued
GLUTETHIMIDE 500MG · TABLET · ORAL

Approval history

2000-01-19Manufacturing (CMC) · Supplement 54AP
1991-08-08Labeling · Supplement 52AP
1987-01-15Manufacturing (CMC) · Supplement 51AP
1986-10-30Manufacturing (CMC) · Supplement 50AP
1984-11-19Manufacturing (CMC) · Supplement 48AP
1984-06-01Manufacturing (CMC) · Supplement 46AP
1984-01-23Manufacturing (CMC) · Supplement 44AP
1984-01-23Manufacturing (CMC) · Supplement 45AP
1983-01-27Manufacturing (CMC) · Supplement 41AP
1982-12-23Manufacturing (CMC) · Supplement 42AP
1982-06-30Manufacturing (CMC) · Supplement 38AP
1982-06-30Manufacturing (CMC) · Supplement 40AP
1982-06-30Manufacturing (CMC) · Supplement 30AP
1982-06-30Manufacturing (CMC) · Supplement 39AP
1982-06-30Manufacturing (CMC) · Supplement 37AP
1976-10-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →