Application 211477

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 60MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51672-5306FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-5306FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETaro Pharmaceuticals U.S.A., Inc.ANDACurrent