APPLICATION
ANDA083247
TYPE
ANDA
ORIGINAL APPROVAL
1982-01-25
LATEST ACTION
1992-09-24
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Discontinued
Products
NEMBUTALDiscontinued
PENTOBARBITAL SODIUM 200MG · SUPPOSITORY · RECTAL
NEMBUTALDiscontinued
PENTOBARBITAL SODIUM 60MG · SUPPOSITORY · RECTAL
NEMBUTALDiscontinued
PENTOBARBITAL SODIUM 120MG · SUPPOSITORY · RECTAL
NEMBUTALDiscontinued
PENTOBARBITAL SODIUM 30MG · SUPPOSITORY · RECTAL
Approval history
1992-09-24Manufacturing (CMC) · Supplement 4AP
1992-09-24Manufacturing (CMC) · Supplement 2AP
1992-05-22Labeling · Supplement 3AP
1986-04-09Manufacturing (CMC) · Supplement 1AP
1982-01-25OriginalAP
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.