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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078420

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NDA 078420 describes NABUMETONE, which is a drug marketed by Casi Pharms Inc, Chartwell Molecules, Copley Pharm, Impax Labs Inc, Invagen Pharms, Lupin Ltd, Mylan Pharms Inc, Nexgen Pharma Inc, Nostrum Labs Inc, Oxford Pharms, Sandoz, Sciegen Pharms Inc, and Watson Labs, and is included in thirteen NDAs. It is available from thirty 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 suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 078420
Applicant:Sciegen Pharms Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 078420
Mechanism of ActionCyclooxygenase Inhibitors
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 ScieGen Pharmaceuticals Inc 50228-465 50228-465-01 100 TABLET in 1 BOTTLE (50228-465-01)
NABUMETONE nabumetone TABLET;ORAL 078420 ANDA ScieGen Pharmaceuticals Inc 50228-465 50228-465-05 500 TABLET in 1 BOTTLE (50228-465-05)

Profile for product number 001

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

Profile for product number 002

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

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