FDA.report

Application 040156

Type
ANDA
Sponsor
IMPAX LABS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 25MG HYDROCHLORIDENoNo
002HYDROXYZINE PAMOATEHYDROXYZINE PAMOATECAPSULE;ORALEQ 50MG HYDROCHLORIDENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1670Hydroxyzine PamoateHydroxyzine PamoateImpax GenericsANDACurrent
0115-1670Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1671Hydroxyzine PamoateHydroxyzine PamoateImpax GenericsANDACurrent
0115-1671Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1803Hydroxyzine PamoateHydroxyzine PamoateImpax GenericsANDACurrent
0115-1803Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1803Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1803Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1803Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1803Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1804Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1804Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1804Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1804Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1804Hydroxyzine PamoateHydroxyzine PamoateAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1804Hydroxyzine PamoateHydroxyzine PamoateImpax GenericsANDACurrent
0615-8419Hydroxyzine PamoateHydroxyzine PamoateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8420Hydroxyzine PamoateHydroxyzine PamoateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-556Hydroxyzine PamoateHydroxyzine PamoateBlenheim Pharmacal, Inc.ANDACurrent
21695-573Hydroxyzine PamoateHydroxyzine PamoateRebel Distributors CorpANDACurrent
42291-322Hydroxyzine PamoateHydroxyzine PamoateAvKARE, Inc.ANDACurrent
42291-323Hydroxyzine PamoateHydroxyzine PamoateAvKARE, Inc.ANDACurrent
42291-406Hydroxyzine PamoateHydroxyzine PamoateAvKAREANDACurrent
42291-406Hydroxyzine PamoateHydroxyzine PamoateAvKARE, Inc.ANDACurrent
42291-407Hydroxyzine PamoateHydroxyzine PamoateAvKARE, Inc.ANDACurrent
42291-407Hydroxyzine PamoateHydroxyzine PamoateAvKAREANDACurrent
43353-199Hydroxyzine PamoateHydroxyzine PamoateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-4471Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50090-4471Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50090-4579Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50090-4579Hydroxyzine PamoateHydroxyzine PamoateA-S Medication SolutionsANDACurrent
50268-398Hydroxyzine PamoateHydroxyzine PamoateAvPAKANDACurrent
50268-398Hydroxyzine PamoateHydroxyzine PamoateAvPAKANDACurrent
50268-398Hydroxyzine PamoateHydroxyzine PamoateAvPAKANDACurrent
50268-399Hydroxyzine PamoateHydroxyzine PamoateAvPAKANDACurrent
50268-399Hydroxyzine PamoateHydroxyzine PamoateAvPAKANDACurrent
50268-399Hydroxyzine PamoateHydroxyzine PamoateAvPAKANDACurrent
53808-0426Hydroxyzine PamoateHYDROXYZINE PAMOATEState of Florida DOH Central PharmacyANDACurrent
53808-0429Hydroxyzine PamoateHYDROXYZINE PAMOATEState of Florida DOH Central PharmacyANDACurrent
55700-860Hydroxyzine PamoateHydroxyzine PamoateQuality Care Products, LLCANDACurrent
55700-860Hydroxyzine PamoateHydroxyzine PamoateQuality Care Products, LLCANDACurrent
55700-860Hydroxyzine PamoateHydroxyzine PamoateQuality Care Products, LLCANDACurrent
55700-860Hydroxyzine PamoateHydroxyzine PamoateQuality Care Products, LLCANDACurrent
55700-860Hydroxyzine PamoateHydroxyzine PamoateQuality Care Products, LLCANDACurrent
55700-860Hydroxyzine PamoateHydroxyzine PamoateQuality Care Products, LLCANDACurrent
63187-034Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
63187-034Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
63629-5415Hydroxyzine PamoateHydroxyzine PamoateBryant Ranch PrepackANDACurrent
64725-0800Hydroxyzine PamoateHydroxyzine PamoateTYA PharmaceuticalsANDACurrent
64725-0801Hydroxyzine PamoateHydroxyzine PamoateTYA PharmaceuticalsANDACurrent
67046-283Hydroxyzine PamoateHydroxyzine PamoateContract Pharmacy Services-PAANDACurrent
67296-1660Hydroxyzine PamoateHydroxyzine PamoateRedPharm Drug, Inc.ANDACurrent
67296-1660Hydroxyzine PamoateHydroxyzine PamoateRedPharm Drug, Inc.ANDACurrent
67296-1660Hydroxyzine PamoateHydroxyzine PamoateRedPharm Drug, Inc.ANDACurrent
68071-2573Hydroxyzine PamoateHydroxyzine PamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4509Hydroxyzine PamoateHydroxyzine PamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4915Hydroxyzine PamoateHydroxyzine PamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4915Hydroxyzine PamoateHydroxyzine PamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7280Hydroxyzine PamoateHydroxyzine PamoatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7280Hydroxyzine PamoateHydroxyzine PamoatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7280Hydroxyzine PamoateHydroxyzine PamoatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7564Hydroxyzine PamoateHydroxyzine PamoatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7564Hydroxyzine PamoateHydroxyzine PamoatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7564Hydroxyzine PamoateHydroxyzine PamoatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0883Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-1411Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-1411Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-1411Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-1411Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70518-3194Hydroxyzine PamoateHydroxyzine PamoateREMEDYREPACK INC.ANDACurrent
70934-444Hydroxyzine PamoateHydroxyzine PamoateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-087Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71205-087Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71205-087Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71205-123Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71205-123Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71205-123Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71205-123Hydroxyzine PamoateHydroxyzine PamoateProficient Rx LPANDACurrent
71335-0998Hydroxyzine PamoateHydroxyzine PamoateBryant Ranch PrepackANDACurrent
71335-0998Hydroxyzine PamoateHydroxyzine PamoateBryant Ranch PrepackANDACurrent