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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091083

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NDA 091083 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 091083
Tradename:NABUMETONE
Applicant:Watson Labs
Ingredient:nabumetone
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091083
Suppliers and Packaging for NDA: 091083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NABUMETONE nabumetone TABLET;ORAL 091083 ANDA Actavis Pharma, Inc. 0591-3670 N 0591-3670-05
NABUMETONE nabumetone TABLET;ORAL 091083 ANDA Actavis Pharma, Inc. 0591-3670 N 0591-3670-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jun 13, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Jun 13, 2011TE:ABRLD:No

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