Details for New Drug Application (NDA): 210437

NDA 210437 describes ROCURONIUM BROMIDE, which is a drug marketed by Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Institutional, Norvium Bioscience, Piramal Critical, Prinston Inc, Sagent Pharms Inc, Sandoz, Shandong, Steriscience, Tamarang, Teva Pharms, and West Ward Pharm Corp, and is included in eighteen NDAs. It is available from twenty-three suppliers. 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-three suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for 210437

Tradename:	ROCURONIUM BROMIDE
Applicant:	Piramal Critical
Ingredient:	rocuronium bromide
Patents:	0

Pharmacology for NDA: 210437

Physiological Effect

Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 210437

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	210437	ANDA	Piramal Critical Care Inc	66794-228	66794-228-41	10 VIAL in 1 CARTON (66794-228-41) / 5 mL in 1 VIAL (66794-228-02)
ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	210437	ANDA	Piramal Critical Care Inc	66794-229	66794-229-41	10 VIAL in 1 CARTON (66794-229-41) / 10 mL in 1 VIAL (66794-229-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/5ML (10MG/ML)
Approval Date:	Aug 13, 2019	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/10ML (10MG/ML)
Approval Date:	Aug 13, 2019	TE:	AP	RLD:	No

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