Application 214645

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	EQ 0.25% BASE	No	No
002	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	EQ 0.5% BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-457	Timolol Maleate Ophthalmic Gel Forming Solution	Timolol Maleate Ophthalmic Gel Forming Solution	Gland Pharma Limited	ANDA	Current
72266-199	Timolol Maleate Ophthalmic Gel Forming Solution	Timolol Maleate Ophthalmic Gel Forming Solution	FOSUN PHARMA USA INC	ANDA	Current