Application 050023

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SUSPENSION/DROPS;OPHTHALMIC	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0792	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0998-0630	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0998-0630	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0998-0630	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0998-0630	Maxitrol	neomycin sulfate, polymyxin b sulfate and dexamethasone	Alcon Laboratories, Inc.	NDA	Current