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Generated: November 14, 2018

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Details for New Drug Application (NDA): 019583

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NDA 019583 describes RELAFEN, which is a drug marketed by Smithkline Beecham and is included in one NDA. Additional details are available on the RELAFEN profile page.

The generic ingredient in RELAFEN is nabumetone. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 019583
Tradename:RELAFEN
Applicant:Smithkline Beecham
Ingredient:nabumetone
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 24, 1991TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 24, 1991TE:RLD:Yes

Expired US Patents for NDA 019583

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham RELAFEN nabumetone TABLET;ORAL 019583-001 Dec 24, 1991 ➤ Sign Up ➤ Sign Up
Smithkline Beecham RELAFEN nabumetone TABLET;ORAL 019583-002 Dec 24, 1991 ➤ Sign Up ➤ Sign Up
Smithkline Beecham RELAFEN nabumetone TABLET;ORAL 019583-002 Dec 24, 1991 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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