APPLICATION
NDA020551
TYPE
NDA
ORIGINAL APPROVAL
1995-12-15
LATEST ACTION
2022-10-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NIMBEX PRESERVATIVE FREE · ReferenceDiscontinued
CISATRACURIUM BESYLATE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NIMBEX PRESERVATIVE FREE · ReferenceDiscontinued
CISATRACURIUM BESYLATE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NIMBEX · ReferenceDiscontinued
CISATRACURIUM BESYLATE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2022-10-07Labeling · Supplement 29 · standardAP
2013-04-01Manufacturing (CMC) · Supplement 23 · standardAP
2002-10-15Manufacturing (CMC) · Supplement 11 · standardAP
2000-02-25Labeling · Supplement 8 · standardAP
2000-02-25Labeling · Supplement 7 · standardAP
1999-05-21Labeling · Supplement 4 · standardAP
1999-05-21Labeling · Supplement 5 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 6 · standardAP
1998-10-15Efficacy · Supplement 3 · standardAP
1998-06-19Labeling · Supplement 2 · standardAP
1995-12-15Type 2 - New Active Ingredient · Original · standardAP
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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