Application 209695

Type
ANDA
Sponsor
INVENTIA HLTHCARE

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
75834-148FluoxetineFLUOXETINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-148FluoxetineFLUOXETINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-148FluoxetineFLUOXETINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-148FluoxetineFLUOXETINE HYDROCHLORIDENivagen Pharmaceuticals, Inc.ANDACurrent