APPLICATION
ANDA074741
TYPE
ANDA
ORIGINAL APPROVAL
1997-03-28
LATEST ACTION
2003-04-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ATRACURIUM BESYLATE PRESERVATIVE FREEDiscontinued
ATRACURIUM BESYLATE 10MG/ML · INJECTABLE · INJECTION
Approval history
2003-04-11Labeling · Supplement 14AP
2001-09-21Manufacturing (CMC) · Supplement 6AP
2000-04-28Manufacturing (CMC) · Supplement 12AP
1999-06-18Manufacturing (CMC) · Supplement 11AP
1998-09-04Manufacturing (CMC) · Supplement 8AP
1998-09-04Manufacturing (CMC) · Supplement 10AP
1998-05-06Labeling · Supplement 3AP
1997-06-04Manufacturing (CMC) · Supplement 2AP
1997-06-04Manufacturing (CMC) · Supplement 1AP
1997-03-28OriginalAP
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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