Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203183
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/26/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2016 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

CISATRACURIUM BESYLATE

INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203183 FRESENIUS KABI USA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 209334 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211668 NANJING KING-FRIEND
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211669 NANJING KING-FRIEND
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200159 SANDOZ INC
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 209132 SOMERSET
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 212171 ZYDUS PHARMS
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203182 FRESENIUS KABI USA
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204960 JIANGSU HENGRUI MED
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200154 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206791 SOMERSET THERAPS LLC
NIMBEX CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE
NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020551 ABBVIE

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