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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091489

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NDA 091489 describes ATRACURIUM BESYLATE, which is a drug marketed by Baxter Hlthcare, Baxter Hlthcare Corp, Eugia Pharma, Hikma, Hospira, Hospira Inc, Meitheal, Pharmobedient, Teva Parenteral, Watson Pharms Teva, and Watson Labs Inc, and is included in twenty-two NDAs. It is available from three suppliers. Additional details are available on the ATRACURIUM BESYLATE profile page.

The generic ingredient in ATRACURIUM BESYLATE is atracurium besylate. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.

Summary for 091489

Tradename:	ATRACURIUM BESYLATE
Applicant:	Meitheal
Ingredient:	atracurium besylate
Patents:	0

Pharmacology for NDA: 091489

Physiological Effect	Neuromuscular Nondepolarizing Blockade

Medical Subject Heading (MeSH) Categories for 091489

Neuromuscular Nondepolarizing Agents
Nicotinic Antagonists

Suppliers and Packaging for NDA: 091489

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATRACURIUM BESYLATE	atracurium besylate	INJECTABLE;INJECTION	091489	ANDA	Meitheal Pharmaceuticals Inc.	71288-702	71288-702-10	10 VIAL, MULTI-DOSE in 1 CARTON (71288-702-10) / 10 mL in 1 VIAL, MULTI-DOSE (71288-702-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Feb 17, 2012	TE:	AP	RLD:	No

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