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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Chubb
Fuji
Mallinckrodt
McKinsey
Johnson and Johnson
Federal Trade Commission
Queensland Health
Colorcon

Generated: December 12, 2017

DrugPatentWatch Database Preview

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. Forty-two suppliers are listed for this compound. Additional details are available on the nabumetone profile page.

Summary for 019583

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 Orange Book Patents for NDA: 019583

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline BeechamRELAFENnabumetoneTABLET;ORAL019583-001Dec 24, 1991► Subscribe► Subscribe
Smithkline BeechamRELAFENnabumetoneTABLET;ORAL019583-002Dec 24, 1991► Subscribe► Subscribe
Smithkline BeechamRELAFENnabumetoneTABLET;ORAL019583-002Dec 24, 1991► Subscribe► Subscribe
Smithkline BeechamRELAFENnabumetoneTABLET;ORAL019583-001Dec 24, 1991► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Baxter
US Army
AstraZeneca
Express Scripts
Cipla
Argus Health
Colorcon
Julphar
Deloitte
Teva

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