Details for New Drug Application (NDA): 211669

NDA 211669 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 211669

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

Pharmacology for NDA: 211669

Physiological Effect

Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 211669

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	211669	ANDA	Meitheal Pharmaceuticals Inc.	71288-714	71288-714-96	10 VIAL, MULTI-DOSE in 1 CARTON (71288-714-96) / 10 mL in 1 VIAL, MULTI-DOSE (71288-714-95)
CISATRACURIUM BESYLATE	cisatracurium besylate	INJECTABLE;INJECTION	211669	ANDA	Meitheal Pharmaceuticals Inc.	71288-714	71288-714-11	10 VIAL, MULTI-DOSE in 1 CARTON (71288-714-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-714-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2MG BASE/ML
Approval Date:	Apr 25, 2019	TE:	AP	RLD:	No

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