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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 219118

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NDA 219118 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 219118

Tradename:	NABUMETONE
Applicant:	Novitium Pharma
Ingredient:	nabumetone
Patents:	0

Pharmacology for NDA: 219118

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 219118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NABUMETONE	nabumetone	TABLET;ORAL	219118	ANDA	ANI Pharmaceuticals, Inc.	70954-784	70954-784-10	100 TABLET, FILM COATED in 1 BOTTLE (70954-784-10)
NABUMETONE	nabumetone	TABLET;ORAL	219118	ANDA	ANI Pharmaceuticals, Inc.	70954-784	70954-784-20	500 TABLET, FILM COATED in 1 BOTTLE (70954-784-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 7, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Jan 7, 2025	TE:	AB	RLD:	No

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