Application 065213

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE	BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	OINTMENT;OPHTHALMIC	400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-7195	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Henry Schein Inc.	ANDA	Current
0404-7195	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Henry Schein Inc.	ANDA	Current
0404-7195	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	Henry Schein Inc.	ANDA	Current
13985-608	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	MWI	ANDA	Current
13985-608	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	MWI	ANDA	Current
13985-608	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone	MWI	ANDA	Current
17478-719	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone	Akorn, Inc.	ANDA	Current
17478-719	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone	Akorn	ANDA	Current
17478-719	Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone	Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone	Akorn, Inc.	ANDA	Current