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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203236
Company: HOSPIRA

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
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG 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
03/30/2018 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
09/18/2023 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
05/29/2020 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
05/29/2020 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
05/29/2020 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

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 217725 CAPLIN
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 215516 GLAND
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204960 HENGRUI PHARMA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 209334 HENGRUI PHARMA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203078 HIKMA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203079 HIKMA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203236 HOSPIRA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203238 HOSPIRA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211668 MEITHEAL
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211669 MEITHEAL
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201836 SAGENT PHARMS INC
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 2MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201851 SAGENT PHARMS INC
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 HENGRUI PHARMA
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

INJECTABLE;INJECTION; EQ 10MG 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 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 217725 CAPLIN
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 215516 GLAND
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203078 HIKMA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203236 HOSPIRA
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211668 MEITHEAL
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201836 SAGENT PHARMS INC
CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 212171 ZYDUS PHARMS
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203182 FRESENIUS KABI USA
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204960 HENGRUI PHARMA
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 200154 SANDOZ INC
CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206791 SOMERSET THERAPS LLC
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