FDA.reportPublic FDA data

Application 088487

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 50MG HYDROCHLORIDENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0302Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0302Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0302Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0302Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0302Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0302Hydroxyzine PamoateHydroxyzine PamoateTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3841Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50090-3908Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50090-3908Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50090-3909Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
51079-078Hydroxyzine PamoateHydroxyzine PamoateMylan Institutional Inc.ANDACurrent
51079-078Hydroxyzine PamoateHydroxyzine PamoateMylan Institutional Inc.ANDACurrent
53808-0374Hydroxyzine PamoateHYDROXYZINE PAMOATEState of Florida DOH Central PharmacyANDACurrent
55154-5092Hydroxyzine PamoateHydroxyzine PamoateCardinal HealthANDACurrent
55154-5092Hydroxyzine PamoateHydroxyzine PamoateCardinal HealthANDACurrent
60687-707Hydroxyzine PamoateHydroxyzine PamoateAmerican Health PackagingANDACurrent
64725-0302Hydroxyzine PamoateHydroxyzine PamoateTYA PharmaceuticalsANDACurrent
70518-3311Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-3311Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-3311Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent