FDA.reportPublic FDA data

Application 091513

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TROSPIUM CHLORIDETROSPIUM CHLORIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-846TROSPIUM CHLORIDETROSPIUM CHLORIDEAvKARE, Inc.ANDACurrent
42291-846TROSPIUM CHLORIDETROSPIUM CHLORIDEAvKAREANDACurrent
60505-3454TROSPIUM CHLORIDETROSPIUM CHLORIDEApotex Corp.ANDACurrent
60505-3454TROSPIUM CHLORIDETROSPIUM CHLORIDEApotex Corp.ANDACurrent