Application 060613

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CASPORYN HC	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SUSPENSION/DROPS;OTIC	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
64980-448	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	neomycin and polymyxin B sulfates and hydrocortisone otic	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-448	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	neomycin and polymyxin B sulfates and hydrocortisone otic	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
64980-448	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	neomycin and polymyxin B sulfates and hydrocortisone otic	Rising Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68788-7787	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	neomycin and polymyxin B sulfates and hydrocortisone otic	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68788-7787	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	neomycin and polymyxin B sulfates and hydrocortisone otic	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
68788-7787	Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension	neomycin and polymyxin B sulfates and hydrocortisone otic	Preferred Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
70199-011	CASPORYN HC	neomycin and polymyxin B sulfates and hydrocortisone otic	Casper Pharma LLC	NDA	Current
70199-011	CASPORYN HC	neomycin and polymyxin B sulfates and hydrocortisone otic	Casper Pharma LLC	NDA	Current