FDA.reportPublic FDA data

Application 075872

Type
ANDA
Sponsor
TEVA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0807FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7188FluoxetineFluoxetineTeva Pharmaceuticals USA,ANDACurrent
55700-180FluoxetineFluoxetineLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-218FluoxetineFluoxetine HydrochlorideProficient Rx LPANDACurrent
63187-218FluoxetineFluoxetine HydrochlorideProficient Rx LPANDACurrent
63187-218FluoxetineFluoxetine HydrochlorideProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44273ORIG2005-08-01
31040ORIG2004-06-04