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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091083

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NDA 091083 describes NABUMETONE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Chartwell Molecules, Chartwell Rx, Copley Pharm, Epic Pharma Llc, Impax Labs Inc, Invagen Pharms, Lgm Pharma, Mpp Pharma, Novitium Pharma, Oxford Pharms, Sciegen Pharms Inc, and Watson Labs, and is included in fourteen NDAs. It is available from twenty-six 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-six 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

Pharmacology for NDA: 091083

Mechanism of Action	Cyclooxygenase Inhibitors

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	0591-3670-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-01)
NABUMETONE	nabumetone	TABLET;ORAL	091083	ANDA	Actavis Pharma, Inc.	0591-3670	0591-3670-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3670-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 13, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Jun 13, 2011	TE:	AB	RLD:	No

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