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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203166

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NDA 203166 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, Nexgen Pharma Inc, Oxford Pharms, Sandoz, Sciegen Pharms Inc, and Watson Labs, and is included in thirteen NDAs. It is available from thirty-three 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-three suppliers are listed for this compound. Additional details are available on the nabumetone profile page.
Summary for 203166
Tradename:NABUMETONE
Applicant:Nexgen Pharma Inc
Ingredient:nabumetone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203166
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 203166
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NABUMETONE nabumetone TABLET;ORAL 203166 ANDA Nexgen Pharma, Inc. 0722-7076 0722-7076-01 100 TABLET, FILM COATED in 1 BOTTLE (0722-7076-01)
NABUMETONE nabumetone TABLET;ORAL 203166 ANDA Nexgen Pharma, Inc. 0722-7076 0722-7076-05 500 TABLET, FILM COATED in 1 BOTTLE (0722-7076-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 30, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Aug 30, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Aug 30, 2019TE:RLD:No

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