FDA.reportPublic FDA data

Application 088488

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 100MG HYDROCHLORIDENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0324Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0324Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0324Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0324Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0324Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0324Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
43063-251Hydroxyzine PamoateHydroxyzine PamoatePD-Rx Pharmaceuticals, Inc.ANDACurrent
53808-0431Hydroxyzine PamoateHYDROXYZINE PAMOATEState of Florida DOH Central PharmacyANDACurrent
63629-9244Hydroxyzine PamoateHydroxyzine PamoateBryant Ranch PrepackANDACurrent
70518-2769Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-2769Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent