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

Summary for NDA: 019583

Tradename:
RELAFEN
Applicant:
Smithkline Beecham
Ingredient:
nabumetone
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Dec 24, 1991TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG
Approval Date:Dec 24, 1991TE:RLD:No

Expired Orange Book Patents for NDA: 019583

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham
RELAFEN
nabumetone
TABLET;ORAL019583-001Dec 24, 19914,061,779► subscribe
Smithkline Beecham
RELAFEN
nabumetone
TABLET;ORAL019583-002Dec 24, 19914,420,639*PED► subscribe
Smithkline Beecham
RELAFEN
nabumetone
TABLET;ORAL019583-002Dec 24, 19914,061,779► subscribe
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