FDA.reportPublic FDA data

Application 091099

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPRAMINE PAMOATEIMIPRAMINE PAMOATECAPSULE;ORALEQ 75MG HYDROCHLORIDENoYes
002IMIPRAMINE PAMOATEIMIPRAMINE PAMOATECAPSULE;ORALEQ 100MG HYDROCHLORIDENoNo
003IMIPRAMINE PAMOATEIMIPRAMINE PAMOATECAPSULE;ORALEQ 125MG HYDROCHLORIDENoNo
004IMIPRAMINE PAMOATEIMIPRAMINE PAMOATECAPSULE;ORALEQ 150MG HYDROCHLORIDENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0273Imipramine PamoateImipramine PamoateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0273Imipramine PamoateImipramine PamoateHikma Pharmaceuticals USA IncANDACurrent
0054-0273Imipramine PamoateImipramine PamoateWest-Ward PharmaceuticalsANDACurrent
0054-0274Imipramine PamoateImipramine PamoateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0274Imipramine PamoateImipramine PamoateHikma Pharmaceuticals USA IncANDACurrent
0054-0274Imipramine PamoateImipramine PamoateWest-Ward PharmaceuticalsANDACurrent
0054-0275Imipramine PamoateImipramine PamoateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0275Imipramine PamoateImipramine PamoateHikma Pharmaceuticals USA IncANDACurrent
0054-0275Imipramine PamoateImipramine PamoateWest-Ward PharmaceuticalsANDACurrent
0054-0276Imipramine PamoateImipramine PamoateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0276Imipramine PamoateImipramine PamoateHikma Pharmaceuticals USA IncANDACurrent
0054-0276Imipramine PamoateImipramine PamoateWest-Ward PharmaceuticalsANDACurrent