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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. 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. Nine suppliers are listed for this compound. Additional details are available on the rocuronium bromide profile page.

Summary for NDA: 020214

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

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 0052-0450-15 10 VIAL, MULTI-DOSE in 1 CARTON (0052-0450-15) > 5 mL in 1 VIAL, MULTI-DOSE

Summary 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(10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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(10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary 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(10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Expired Orange Book Patents for NDA: 020214

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc
ZEMURON
rocuronium bromide
INJECTABLE;INJECTION020214-001Mar 17, 19944,894,369*PED► subscribe
Organon Usa Inc
ZEMURON
rocuronium bromide
INJECTABLE;INJECTION020214-003Mar 17, 19944,894,369*PED► subscribe
Organon Usa Inc
ZEMURON
rocuronium bromide
INJECTABLE;INJECTION020214-002Mar 17, 19944,894,369*PED► subscribe
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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.

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