← FDA DRUG APPROVALS

FDA NDA · NDA014882

MEPROBAMATE

Sponsor: CHARTWELL MOLECULAR

APPLICATION
NDA014882
TYPE
NDA
ORIGINAL APPROVAL
1963-08-09
LATEST ACTION
1986-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1986-08-22Labeling · Supplement 11AP
1981-09-22Manufacturing (CMC) · Supplement 9 · standardAP
1978-10-24Manufacturing (CMC) · Supplement 8 · standardAP
1978-04-25Labeling · Supplement 7AP
1977-09-08Manufacturing (CMC) · Supplement 6 · standardAP
1977-09-08Labeling · Supplement 5AP
1963-08-09Type 5 - New Formulation or New Manufacturer · Original · standardAP
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 →