FDA.reportPublic FDA data

Application 076015

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDESOLUTION;ORALEQ 20MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-0721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent
0121-4721FluoxetineFLUOXETINE HYDROCHLORIDEPharmaceutical Associates, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53970ORIG2018-05-01
23792ORIG2005-08-01