Last Updated: November 8, 2026

Details for New Drug Application (NDA): 090427

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NDA 090427 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, Novitium Pharma, Pharmazone, Sciegen Pharms, Tp Anda Holdings, and Watson Labs, and is included in fourteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the NABUMETONE profile page.

The generic ingredient in NABUMETONE is nabumetone. There is one drug master file entry for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the nabumetone profile page.

Summary for 090427

Tradename:	NABUMETONE
Applicant:	Pharmazone
Ingredient:	nabumetone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Dec 30, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Dec 30, 2011	TE:		RLD:	No

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