FDA.reportPublic FDA data

Application 211282

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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
50228-422FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.ANDACurrent
50228-422FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.ANDACurrent
50228-422FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.ANDACurrent
50228-422FluoxetineFLUOXETINE HYDROCHLORIDEScieGen Pharmaceuticals, Inc.ANDACurrent
51407-196FluoxetineFLUOXETINE HYDROCHLORIDEGolden State Medical Supply IncANDACurrent
51407-196FluoxetineFLUOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
51407-196FluoxetineFLUOXETINE HYDROCHLORIDEGolden State Medical SupplyANDACurrent
51407-196FluoxetineFLUOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent