APPLICATION
NDA018831
TYPE
NDA
ORIGINAL APPROVAL
1983-11-23
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRACRIUM PRESERVATIVE FREE · ReferenceDiscontinued
ATRACURIUM BESYLATE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
TRACRIUM · ReferenceDiscontinued
ATRACURIUM BESYLATE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 6AP
2009-03-13Labeling · Supplement 10AP
2000-10-03Labeling · Supplement 22 · standardAP
2000-10-03Labeling · Supplement 21 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 23 · priorityAP
1995-06-08Manufacturing (CMC) · Supplement 20 · priorityAP
1994-06-06Efficacy · Supplement 19 · priorityAP
1994-06-01Labeling · Supplement 18 · standardAP
1992-10-06Labeling · Supplement 16AP
1992-10-06Labeling · Supplement 17 · standardAP
1990-07-06Labeling · Supplement 15AP
1989-05-19Labeling · Supplement 14AP
1986-12-11Labeling · Supplement 13AP
1986-10-29Efficacy · Supplement 11AP
1986-10-29Manufacturing (CMC) · Supplement 12 · priorityAP
1986-10-29Manufacturing (CMC) · Supplement 7 · priorityAP
1986-02-14Efficacy · Supplement 8AP
1985-09-11Labeling · Supplement 4AP
1985-06-24Labeling · Supplement 5AP
1985-06-20Labeling · Supplement 2AP
1985-06-20Manufacturing (CMC) · Supplement 1 · priorityAP
1984-12-17Manufacturing (CMC) · Supplement 3 · priorityAP
1983-11-23Type 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.
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