FDA.reportPublic FDA data

Application 062351

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATEOINTMENT;TOPICALEQ 0.1% BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-046Gentamicin SulfateGentamicin SulfatePerrigo New York IncANDACurrent
45802-046Gentamicin SulfateGentamicin SulfatePadagis Israel Pharmaceuticals LtdANDACurrent