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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075280

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NDA 075280 describes NABUMETONE, which is a drug marketed by Apotex Inc, Casi Pharms Inc, Chartwell Molecules, Copley Pharm, Impax Labs Inc, Invagen Pharms, Lupin Ltd, Mylan Pharms Inc, Oxford Pharms, Sandoz, Sciegen Pharms Inc, and Watson Labs, and is included in twelve NDAs. It is available from twenty-nine suppliers. Additional details are available on the NABUMETONE profile page.

The generic ingredient in NABUMETONE is nabumetone. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 075280
Tradename:NABUMETONE
Applicant:Casi Pharms Inc
Ingredient:nabumetone
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075280
Suppliers and Packaging for NDA: 075280
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NABUMETONE nabumetone TABLET;ORAL 075280 ANDA Eon Labs, Inc. 0185-0145 N 0185-0145-05
NABUMETONE nabumetone TABLET;ORAL 075280 ANDA Eon Labs, Inc. 0185-0145 N 0185-0145-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Feb 25, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Feb 25, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Argus Health
Dow
Chubb
Cantor Fitzgerald
Fish and Richardson
Julphar
QuintilesIMS
Farmers Insurance

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