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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078420

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NDA 078420 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 thirty-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. Thirty-nine suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 078420
Applicant:Sciegen Pharms Inc
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078420
Suppliers and Packaging for NDA: 078420
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NABUMETONE nabumetone TABLET;ORAL 078420 ANDA Dr. Reddy's Laboratories Limited 55111-486 N 55111-486-30
NABUMETONE nabumetone TABLET;ORAL 078420 ANDA Dr. Reddy's Laboratories Limited 55111-486 N 55111-486-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Sep 24, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG
Approval Date:Sep 24, 2008TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Boehringer Ingelheim
Fish and Richardson

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