Last Updated: September 27, 2026

Details for New Drug Application (NDA): 021664

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NDA 021664 describes XIBROM, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. Additional details are available on the XIBROM profile page.

The generic ingredient in XIBROM is bromfenac sodium. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bromfenac sodium profile page.

Summary for 021664

Tradename:	XIBROM
Applicant:	Bausch And Lomb Inc
Ingredient:	bromfenac sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 24, 2005	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 16, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 021664

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	XIBROM	bromfenac sodium	SOLUTION/DROPS;OPHTHALMIC	021664-001	Mar 24, 2005	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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