APPLICATION
ANDA085880
TYPE
ANDA
ORIGINAL APPROVAL
1978-08-30
LATEST ACTION
2019-02-06
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
BUTALANDiscontinued
BUTABARBITAL SODIUM 33.3MG/5ML · ELIXIR · ORAL
Approval history
2019-02-06Labeling · Supplement 1 · standardAP
1978-08-30OriginalAP
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.