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Serving leading biopharmaceutical companies globally:

US Army
Julphar
Teva
Cipla
Accenture
Dow
Express Scripts
Queensland Health
US Department of Justice
Federal Trade Commission

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090516

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NDA 090516 describes NABUMETONE, which is a drug marketed by Apotex Inc, Chartwell Molecules, Copley Pharm, Dr Reddys Labs Ltd, Impax Labs Inc, Invagen Pharms, Lupin Ltd, Mylan Pharms Inc, Oxford Pharms, Sandoz, and Watson Labs, and is included in twelve NDAs. It is available from forty-two 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. Forty-two suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 090516
Tradename:NABUMETONE
Applicant:Mylan Pharms Inc
Ingredient:nabumetone
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090516
Suppliers and Packaging for NDA: 090516
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NABUMETONE nabumetone TABLET;ORAL 090516 ANDA Mylan Pharmaceuticals Inc. 0378-3015 0378-3015-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3015-05)
NABUMETONE nabumetone TABLET;ORAL 090516 ANDA Mylan Pharmaceuticals Inc. 0378-3015 0378-3015-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3015-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 12, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jul 12, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Novartis
Queensland Health
Boehringer Ingelheim
UBS
McKinsey
Julphar
Farmers Insurance
Daiichi Sankyo
Deloitte

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