Application 021664

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIBROM	BROMFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	BROMDAY	BROMFENAC SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.09% ACID Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-6301	Bromday	bromfenac	Unit Dose Services	NDA	Current