Application 062531

Type
ANDA
Sponsor
FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATECREAM;TOPICALEQ 0.1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0071Gentamicin Sulfategentamicin sulfateE. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.ANDACurrent
55045-1147Gentamicin Sulfategentamicin sulfateDispensing Solutions, Inc.ANDACurrent