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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 203079

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NDA 203079 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 203079

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

Pharmacology for NDA: 203079

Physiological Effect	Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 203079

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	203079	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9397	0143-9397-10	10 VIAL in 1 CARTON (0143-9397-10) / 10 mL in 1 VIAL (0143-9397-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML
Approval Date:	Apr 19, 2023	TE:	AP	RLD:	No

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