APPLICATION
ANDA076770
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-23
LATEST ACTION
2011-04-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TERBUTALINE SULFATEDiscontinued
TERBUTALINE SULFATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2011-04-08Labeling · Supplement 6AP
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.