APPLICATION
ANDA070546
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-14
LATEST ACTION
1994-06-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BRETYLIUM TOSYLATEDiscontinued
BRETYLIUM TOSYLATE 50MG/ML · INJECTABLE · INJECTION
Approval history
1994-06-22Labeling · Supplement 6AP
1990-04-09Labeling · Supplement 4AP
1990-04-03Manufacturing (CMC) · Supplement 5AP
1989-01-24Manufacturing (CMC) · Supplement 3AP
1986-11-03Manufacturing (CMC) · Supplement 2AP
1986-06-04Labeling · Supplement 1AP
1986-05-14OriginalAP
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.