← FDA DRUG APPROVALS

FDA ANDA · ANDA080699

MEPROBAMATE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA080699
TYPE
ANDA
ORIGINAL APPROVAL
1972-10-16
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEPROBAMATEDiscontinued
MEPROBAMATE 400MG · TABLET · ORAL
MEPROBAMATEDiscontinued
MEPROBAMATE 200MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 130AP
1994-12-23Manufacturing (CMC) · Supplement 129AP
1992-04-03Manufacturing (CMC) · Supplement 128AP
1992-04-03Manufacturing (CMC) · Supplement 126AP
1992-04-03Manufacturing (CMC) · Supplement 124AP
1992-04-03Manufacturing (CMC) · Supplement 125AP
1992-04-03Manufacturing (CMC) · Supplement 123AP
1989-03-15Labeling · Supplement 122AP
1988-10-13Labeling · Supplement 121AP
1986-03-12Manufacturing (CMC) · Supplement 118AP
1972-10-16OriginalAP
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 →