APPLICATION
ANDA074901
TYPE
ANDA
ORIGINAL APPROVAL
1997-07-18
LATEST ACTION
2018-07-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ATRACURIUM BESYLATEPrescription
ATRACURIUM BESYLATE 10MG/ML · INJECTABLE · INJECTION
Approval history
2018-07-26Labeling · Supplement 20 · standardAP
2010-11-23Labeling · Supplement 12AP
2002-06-27Manufacturing (CMC) · Supplement 1AP
2001-04-03Manufacturing (CMC) · Supplement 2AP
2001-03-26Labeling · Supplement 3AP
1997-07-18OriginalAP
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.