FDA.reportPublic FDA data

Application 065088

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-7194Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincHenry Schein Inc.ANDACurrent
0404-7194Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincHenry Schein Inc.ANDACurrent
0404-7194Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincHenry Schein Inc.ANDACurrent
13985-607Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincMWIANDACurrent
13985-607Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincMWIANDACurrent
13985-607Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincMWIANDACurrent
17478-235Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincAkorn, Inc.ANDACurrent
17478-235Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincAkornANDACurrent
17478-235Neomycin and Polymyxin B Sulfates, and Bacitracin ZincNeomycin Sulfate, Polymyxin B Sulfate and Bacitracin ZincAkorn, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30651ORIG2004-06-09