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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219108

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NDA 219108 describes ROCURONIUM BROMIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Institutional, Piramal Critical, Prinston Inc, Rising, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, West Ward Pharm Corp, and Sterinova Inc, and is included in twenty-one NDAs. It is available from twenty-four 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-four suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for 219108

Tradename:	ROCURONIUM BROMIDE
Applicant:	Sterinova Inc
Ingredient:	rocuronium bromide
Patents:	1

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:	⤷ Get Started Free	Patent Expiration:	Jul 22, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

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