Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
Deloitte
Dow
AstraZeneca
Farmers Insurance
Accenture
Fuji
Merck
Chubb

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020214

« Back to Dashboard

NDA 020214 describes ZEMURON, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from one supplier. 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. Twelve 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
Pharmacology for NDA: 020214
Suppliers and Packaging for NDA: 020214
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214 NDA Organon USA Inc. 0052-0450 N 0052-0450-15

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(10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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(10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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(10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 020214-001 Mar 17, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-002 Mar 17, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Organon Usa Inc ZEMURON rocuronium bromide INJECTABLE;INJECTION 020214-003 Mar 17, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Colorcon
Johnson and Johnson
Mallinckrodt
Julphar
Teva
Federal Trade Commission
US Department of Justice
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot