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Abbreviated New Drug Application (ANDA): 211669
Company: MEITHEAL

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 Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/25/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211669Orig1s000ltr.pdf

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 209144 EUGIA PHARMA
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 216538 HAINAN POLY
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 215516 PIRAMAL CRITICAL
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 209665 EUGIA PHARMA
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
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