Last Updated: May 3, 2026

Details for New Drug Application (NDA): 219108

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NDA 219108 describes ROCURONIUM BROMIDE, which is a drug marketed by Aspiro, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Knack, Mankind Pharma, Meitheal, Mylan Institutional, Piramal Critical, Prinston Inc, Rising, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, West Ward Pharm Corp, and B Braun Medical, and is included in twenty-three NDAs. It is available from twenty-five suppliers. There is one patent protecting this drug. Additional details are available on the ROCURONIUM BROMIDE profile page.

The generic ingredient in ROCURONIUM BROMIDE is rocuronium bromide. There are eleven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for 219108

Tradename:	ROCURONIUM BROMIDE
Applicant:	B Braun Medical
Ingredient:	rocuronium bromide
Patents:	1

Pharmacology for NDA: 219108

Physiological Effect	Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 219108

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROCURONIUM BROMIDE	rocuronium bromide	SOLUTION;INTRAVENOUS	219108	NDA	B. Braun Medical Inc.	0264-5711	0264-5711-10	30 CARTON in 1 CASE (0264-5711-10) / 10 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE (0264-5711-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Oct 24, 2025	TE:		RLD:	Yes
Patent:	11,998,605	Patent Expiration:	Jul 22, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

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