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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203238

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NDA 203238 describes CISATRACURIUM BESYLATE, which is a drug marketed by Accord Hlthcare, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hainan Poly, Hengrui Pharma, Hikma, Hospira, Meitheal, Piramal, Sagent Pharms Inc, Sandoz Inc, Somerset, Zydus Pharms, and Somerset Theraps Llc, and is included in twenty-six NDAs. It is available from fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the cisatracurium besylate profile page.

Summary for 203238

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

Pharmacology for NDA: 203238

Physiological Effect	Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 203238

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203238	ANDA	Hospira, Inc.	0409-1208	0409-1208-01	10 VIAL, MULTI-DOSE in 1 CARTON (0409-1208-01) / 10 mL in 1 VIAL, MULTI-DOSE (0409-1208-11)

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

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