FDA.reportPublic FDA data

Application 211051

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-5262FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5262FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5262FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5262FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5262FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent