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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 017851


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NDA 017851 describes LIORESAL, which is a drug marketed by Amneal and Novartis and is included in two NDAs. It is available from two suppliers. Additional details are available on the LIORESAL profile page.

The generic ingredient in LIORESAL is baclofen. There are twenty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.
Summary for 017851
Tradename:LIORESAL
Applicant:Novartis
Ingredient:baclofen
Patents:0
Medical Subject Heading (MeSH) Categories for 017851

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 20, 1982TE:RLD:Yes

Expired US Patents for NDA 017851

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LIORESAL baclofen TABLET;ORAL 017851-001 Approved Prior to Jan 1, 1982 ⤷  Sign Up ⤷  Sign Up
Novartis LIORESAL baclofen TABLET;ORAL 017851-003 Jan 20, 1982 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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