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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078671

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NDA 078671 describes NABUMETONE, which is a drug marketed by Apotex 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 forty 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 suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 078671
Tradename:NABUMETONE
Applicant:Invagen Pharms
Ingredient:nabumetone
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078671
Suppliers and Packaging for NDA: 078671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NABUMETONE nabumetone TABLET;ORAL 078671 ANDA Liberty Pharmaceuticals, Inc. 0440-5843 N 0440-5843-95
NABUMETONE nabumetone TABLET;ORAL 078671 ANDA Liberty Pharmaceuticals, Inc. 0440-5843 N 0440-5843-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 7, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Mar 7, 2008TE:ABRLD:No

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