APPLICATION
ANDA206404
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-23
LATEST ACTION
2023-08-15
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PENTOBARBITAL SODIUMPrescription
PENTOBARBITAL SODIUM 50MG/ML · INJECTABLE · INJECTION
Approval history
2023-08-15Labeling · Supplement 5 · standardAP
2017-04-27Labeling · Supplement 3 · standardAP
2016-05-23UNKNOWN · Original · standardAP
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.