Details for New Drug Application (NDA): 203236

NDA 203236 describes CISATRACURIUM BESYLATE, which is a drug marketed by Accord Hlthcare, Caplin, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal, Piramal Critical, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, and Somerset Theraps Llc, and is included in twenty-eight NDAs. It is available from sixteen suppliers. Additional details are available on the CISATRACURIUM BESYLATE profile page.

The generic ingredient in CISATRACURIUM BESYLATE is cisatracurium besylate. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.

Summary for 203236

Tradename:	CISATRACURIUM BESYLATE
Applicant:	Hospira
Ingredient:	cisatracurium besylate
Patents:	0

Pharmacology for NDA: 203236

Physiological Effect

Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 203236

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203236	ANDA	Hospira, Inc.	0409-1098	0409-1098-02	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1098-02) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1098-12)
CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203236	ANDA	Hospira, Inc.	0409-1103	0409-1103-01	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1103-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1103-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML
Approval Date:	Mar 30, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Mar 30, 2018	TE:	AP	RLD:	No

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