Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 204960
Company: HENGRUI PHARMA

Products on ANDA 204960

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 2MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
CISATRACURIUM BESYLATE PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204960

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2017	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204960Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/31/2020	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204960

CISATRACURIUM BESYLATE PRESERVATIVE FREE

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	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	209334	HENGRUI PHARMA
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	215517	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
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

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	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	215516	PIRAMAL CRITICAL
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
NIMBEX PRESERVATIVE FREE	CISATRACURIUM BESYLATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020551	ABBVIE