Details for New Drug Application (NDA): 020214

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NDA 020214 describes ZEMURON, which is a drug marketed by Organon Usa Inc and is included in one NDA. Additional details are available on the ZEMURON profile page.

The generic ingredient in ZEMURON 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 020214

Tradename:	ZEMURON
Applicant:	Organon Usa Inc
Ingredient:	rocuronium bromide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/5ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 17, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 17, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/10ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 17, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020214

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-001	Mar 17, 1994	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-003	Mar 17, 1994	⤷ Sign Up	⤷ Sign Up
Organon Usa Inc	ZEMURON	rocuronium bromide	INJECTABLE;INJECTION	020214-002	Mar 17, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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