FDA.report

Application 086183

Type
ANDA
Sponsor
SANDOZ

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 50MG HYDROCHLORIDENoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0615hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0615hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0615hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0615hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0615hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0615hydroxyzine pamoatehydroxyzine pamoateEon Labs, Inc.ANDACurrent
0185-0676Hydroxyzine pamoateHydroxyzine PamoateEon Labs, Inc.ANDACurrent
0185-0676Hydroxyzine pamoateHydroxyzine PamoateEon Labs, Inc.ANDACurrent
0185-0676Hydroxyzine pamoateHydroxyzine PamoateEon Labs, Inc.ANDACurrent
0185-0676Hydroxyzine pamoateHydroxyzine PamoateEon Labs, Inc.ANDACurrent
0615-0332Hydroxyzine PamoateHydroxyzine PamoateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-833hydroxyzine pamoatehydroxyzine pamoateApotheca Inc.ANDACurrent
33261-858hydroxyzine pamoatehydroxyzine pamoateAidarex Pharmaceuticals LLCANDACurrent
50090-0374hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-2664hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-5934Hydroxyzine pamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
55700-742hydroxyzine pamoatehydroxyzine pamoateQuality Care Products, LLCANDACurrent
55700-742hydroxyzine pamoatehydroxyzine pamoateQuality Care Products, LLCANDACurrent
61919-647HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
61919-647HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
62584-741Hydroxyzine PamoateHydroxyzine PamoateAmerican Health PackagingANDACurrent
67046-282Hydroxyzine PamoateHYDROXYZINE PAMOATEContract Pharmacy Services-PAANDACurrent
67296-0222hydroxyzine pamoatehydroxyzine pamoateRedPharm Drug, Inc.ANDACurrent
67296-0222hydroxyzine pamoatehydroxyzine pamoateRedPharm Drug, Inc.ANDACurrent
68071-3158hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals, Inc.ANDACurrent
68788-0523hydroxyzine pamoatehydroxyzine pamoatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8111Hydroxyzine pamoateHydroxyzine PamoatePreferred Pharmaceuticals Inc.ANDACurrent
68788-8111Hydroxyzine pamoateHydroxyzine PamoatePreferred Pharmaceuticals Inc.ANDACurrent
70518-1471hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1471hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1659hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-1659hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-3232Hydroxyzine pamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-3232Hydroxyzine pamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
71335-1058hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1058hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-1058hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
71335-2076Hydroxyzine pamoateHydroxyzine PamoateBryant Ranch PrepackANDACurrent