APPLICATION
NDA020098
TYPE
NDA
ORIGINAL APPROVAL
1992-01-22
LATEST ACTION
2018-07-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
SOLUTION, INJECTABLE
MARKETING STATUS
Discontinued
Products
MIVACRON · ReferenceDiscontinued
MIVACURIUM CHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) · SOLUTION · INTRAVENOUS
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
MIVACURIUM CHLORIDE EQ 50MG BASE/100ML · INJECTABLE · INJECTION
MIVACRON · ReferenceDiscontinued
MIVACURIUM CHLORIDE EQ 2MG BASE/ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
MIVACRON · ReferenceDiscontinued
MIVACURIUM CHLORIDE EQ 10MG BASE/5ML (EQ 2MG BASE/ML) · SOLUTION · INTRAVENOUS
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
MIVACURIUM CHLORIDE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
Approval history
2002-10-15Manufacturing (CMC) · Supplement 14 · priorityAP
2001-02-20Labeling · Supplement 12 · standardAP
1999-06-25Labeling · Supplement 10 · standardAP
1999-03-17Manufacturing (CMC) · Supplement 11 · priorityAP
1997-06-04Manufacturing (CMC) · Supplement 8 · priorityAP
1995-06-09Manufacturing (CMC) · Supplement 6 · priorityAP
1995-02-08Labeling · Supplement 1 · standardAP
1994-08-18Manufacturing (CMC) · Supplement 5 · priorityAP
1994-04-15Manufacturing (CMC) · Supplement 3 · priorityAP
1994-03-02Labeling · Supplement 2 · standardAP
1994-01-25Labeling · Supplement 4 · standardAP
1992-01-22Type 1 - New Molecular Entity · Original · priorityAP
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.