FDA.reportPublic FDA data

Application 075452

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
003FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7198FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-398FluoxetineFluoxetineAvKARE, Inc.ANDACurrent
42291-398FluoxetineFluoxetineAvKAREANDACurrent
42291-398FluoxetineFluoxetineAvKAREANDACurrent
53808-0837FluoxetineFluoxetineState of Florida DOH Central PharmacyANDACurrent
67046-210FluoxetineFluoxetineContract Pharmacy Services-PAANDACurrent
70518-1987FluoxetineFluoxetineREMEDYREPACK INC.ANDACurrent
71205-188FluoxetineFluoxetineProficient Rx LPANDACurrent
71205-188FluoxetineFluoxetineProficient Rx LPANDACurrent
71205-188FluoxetineFluoxetineProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23763ORIG2005-08-01
30888ORIG2004-06-04