Cisatracurium Injectable Solution

Brand(s)
Nimbex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Abbvie Inc. (2013-08-20)
Oldest Current Product
1995-12-15
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CISATRACURIUM
FDAOB
INJECTION\INJECTION\CISATRACURIUM BESYLATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\CISATRACURIUM BESYLATE
INTRAVENOUS\INJECTION\CISATRACURIUM BESYLATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\CISATRACURIUM
INTRAVENOUS\INJECTION\CISATRACURIUM

product(s) by strength(s)

cisatracurium 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000744382NimbexNDAAbbvie Inc.1995-12-15CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONNDA0205513db3b76c-3e5a-456e-46a8-456fde1e6195

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813153ANDASandoz Inc2012-07-16CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONANDA200154291a55dd-ab45-4660-b513-4ecb729eb051
2007819039ANDASandoz Inc2013-02-28CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONANDA200154a78873f7-ff02-4ade-93ca-cd8a353a2123
3633230418ANDAApp Pharmaceuticals, Llc2015-02-26CISATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA203182f78a07e2-0d3b-4460-b29e-8c10c90afbda

cisatracurium 2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000744380NimbexNDAAbbvie Inc.2010-12-09CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONNDA0205513db3b76c-3e5a-456e-46a8-456fde1e6195

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813150ANDASandoz Inc2012-07-16CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONANDA200154291a55dd-ab45-4660-b513-4ecb729eb051
2007813152ANDASandoz Inc2012-07-16CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONANDA2001592ee0358e-2cce-40d3-9fcf-1b9088815c98
3007819037ANDASandoz Inc2013-02-28CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONANDA200154a78873f7-ff02-4ade-93ca-cd8a353a2123
4007819038ANDASandoz Inc2013-02-28CISATRACURIUM BESYLATEINTRAVENOUSINJECTIONANDA200159e6202e14-f9d3-49fc-a6a2-14535aea0457
5633230416ANDAApp Pharmaceuticals, Llc2015-02-26CISATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA203182f78a07e2-0d3b-4460-b29e-8c10c90afbda
6633230417ANDAApp Pharmaceuticals, Llc2015-02-26CISATRACURIUM BESYLATEINTRAVENOUSINJECTION, SOLUTIONANDA203183f78a07e2-0d3b-4460-b29e-8c10c90afbda

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA200154CISATRACURIUM BESYLATE PRESERVATIVE FREESANDOZ INC2012-02-03ANDA200154_001, ANDA200154_002
2ANDA200159CISATRACURIUM BESYLATESANDOZ INC2012-02-03ANDA200159_001
3ANDA203182CISATRACURIUM BESYLATE PRESERVATIVE FREEFRESENIUS KABI USA LLC2015-02-26ANDA203182_001, ANDA203182_002
4ANDA203183CISATRACURIUM BESYLATEFRESENIUS KABI USA LLC2015-02-26ANDA203183_001
5NDA020551NIMBEXABBVIE INC1995-12-15NDA020551_001, NDA020551_002, NDA020551_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA200154_001RXCISATRACURIUM BESYLATE (EQ 2MG BASE/ML)INJECTIONFalseAP2012-02-03CISATRACURIUM BESYLATE PRESERVATIVE FREE
2ANDA200154_002RXCISATRACURIUM BESYLATE (EQ 10MG BASE/ML)INJECTIONFalseAP2012-02-03CISATRACURIUM BESYLATE PRESERVATIVE FREE
3ANDA200159_001RXCISATRACURIUM BESYLATE (EQ 2MG BASE/ML)INJECTIONFalseAP2012-02-03CISATRACURIUM BESYLATE
4ANDA203182_001RXCISATRACURIUM BESYLATE (EQ 2MG BASE/ML)INJECTIONFalseAP2015-02-26CISATRACURIUM BESYLATE PRESERVATIVE FREE
5ANDA203182_002RXCISATRACURIUM BESYLATE (EQ 10MG BASE/ML)INJECTIONFalseAP2015-02-26CISATRACURIUM BESYLATE PRESERVATIVE FREE
6ANDA203183_001RXCISATRACURIUM BESYLATE (EQ 2MG BASE/ML)INJECTIONFalseAP2015-02-26CISATRACURIUM BESYLATE
7NDA020551_001RXCISATRACURIUM BESYLATE (EQ 2MG BASE/ML)INJECTIONTrueAP1995-12-15NIMBEX
8NDA020551_002RXCISATRACURIUM BESYLATE (EQ 10MG BASE/ML)INJECTIONTrueAP1995-12-15NIMBEX
9NDA020551_003RXCISATRACURIUM BESYLATE (EQ 2MG BASE/ML)INJECTIONTrueAP1995-12-15NIMBEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1291a55dd-ab45-4660-b513-4ecb729eb051 (view SPL)Cisatracurium Besylate InjectionprescriptionHuman PrescriptionSandoz Inc2014-09-245007813150, 007813153
22ee0358e-2cce-40d3-9fcf-1b9088815c98 (view SPL)Cisatracurium Besylate InjectionprescriptionHuman PrescriptionSandoz Inc2012-07-312007813152
33db3b76c-3e5a-456e-46a8-456fde1e6195 (view SPL)NIMBEX (cisatracurium besylate) InjectionprescriptionHuman PrescriptionAbbvie Inc.2013-08-201411000744380, 000744382, 000744378
4a78873f7-ff02-4ade-93ca-cd8a353a2123 (view SPL)Cisatracurium Besylate InjectionprescriptionHuman PrescriptionSandoz Inc2012-10-151007819037, 007819039
5e6202e14-f9d3-49fc-a6a2-14535aea0457 (view SPL)Cisatracurium Besylate InjectionprescriptionHuman PrescriptionSandoz Inc2012-10-151007819038
6f78a07e2-0d3b-4460-b29e-8c10c90afbda (view SPL)Cisatracurium Besylate InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-092633230416, 633230417, 633230418

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII