FDA.reportPublic FDA data

Application 050417

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOSPORINBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-754Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin and Polymyxin B Sulfates and Bacitracin ZincRising Pharma Holdings, Inc.NDA AUTHORIZED GENERICCurrent
57237-129Neomycin and Polymyxin B sulfates, Bacitracin zincNeomycin and Polymyxin B sulfates, Bacitracin zincCitron Pharma LLCNDACurrent
70199-010Neomycin and Polymyxin B sulfates, Bacitracin zincNeomycin and Polymyxin B sulfates, Bacitracin zincCasper Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63311SUPPL2020-05-28
63277SUPPL2020-05-22
38932SUPPL2004-05-04
30013SUPPL2004-05-04