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Last Updated: May 14, 2021

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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. Fourteen 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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 17, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 17, 1994TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 17, 1994TE:RLD:Yes

Expired US Patents for NDA 020214

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-003 Mar 17, 1994   Get Started for $10   Get Started for $10
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-001 Mar 17, 1994   Get Started for $10   Get Started for $10
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-002 Mar 17, 1994   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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