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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 018831


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NDA 018831 describes TRACRIUM PRESERVATIVE FREE, which is a drug marketed by Hospira and is included in one NDA. Additional details are available on the TRACRIUM PRESERVATIVE FREE profile page.

The generic ingredient in TRACRIUM PRESERVATIVE FREE is atracurium besylate. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the atracurium besylate profile page.
Summary for 018831
Tradename:TRACRIUM PRESERVATIVE FREE
Applicant:Hospira
Ingredient:atracurium besylate
Patents:0
Medical Subject Heading (MeSH) Categories for 018831

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Nov 23, 1983TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 20, 1985TE:RLD:Yes

Expired US Patents for NDA 018831

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hospira TRACRIUM PRESERVATIVE FREE atracurium besylate INJECTABLE;INJECTION 018831-001 Nov 23, 1983 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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