Details for New Drug Application (NDA): 216234

NDA 216234 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-two 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-two suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for 216234

Tradename:	ROCURONIUM BROMIDE
Applicant:	Caplin
Ingredient:	rocuronium bromide
Patents:	0

Pharmacology for NDA: 216234

Physiological Effect

Neuromuscular Nondepolarizing Blockade

Suppliers and Packaging for NDA: 216234

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	216234	ANDA	Caplin Steriles Limited	65145-130	65145-130-10	10 VIAL, MULTI-DOSE in 1 CARTON (65145-130-10) / 5 mL in 1 VIAL, MULTI-DOSE (65145-130-01)
ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	216234	ANDA	Caplin Steriles Limited	65145-131	65145-131-10	10 VIAL, MULTI-DOSE in 1 CARTON (65145-131-10) / 10 mL in 1 VIAL, MULTI-DOSE (65145-131-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/5ML (10MG/ML)
Approval Date:	Mar 2, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/10ML (10MG/ML)
Approval Date:	Mar 2, 2023	TE:	AP	RLD:	No

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