FDA.report

Application 201507

Type
ANDA
Sponsor
HERITAGE PHARMA

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
0615-8356hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8356hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8356hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8357hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8357hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8357hydroxyzine pamoatehydroxyzine pamoateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-7065hydroxyzine pamoatehydroxyzine pamoateMajor PharmaceuticalsANDACurrent
0904-7065hydroxyzine pamoatehydroxyzine pamoateMajor PharmaceuticalsANDACurrent
14539-674hydroxyzine pamoatehydroxyzine pamoateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-674hydroxyzine pamoatehydroxyzine pamoateHeritage Pharma Labs, IncANDACurrent
14539-674hydroxyzine pamoatehydroxyzine pamoateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-675hydroxyzine pamoatehydroxyzine pamoateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-675hydroxyzine pamoatehydroxyzine pamoateHeritage Pharma Labs, IncANDACurrent
14539-675hydroxyzine pamoatehydroxyzine pamoateHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-674hydroxyzine pamoatehydroxyzine pamoateHeritage Pharmaceuticals Inc.ANDACurrent
23155-675hydroxyzine pamoatehydroxyzine pamoateHeritage Pharmaceuticals Inc.ANDACurrent
42495-170HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEWestwood ManufacturingANDACurrent
43353-094HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2984HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEA-S Medication SolutionsANDACurrent
50090-2984HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEA-S Medication SolutionsANDACurrent
50090-3169HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEA-S Medication SolutionsANDACurrent
50090-3284HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEA-S Medication SolutionsANDACurrent
50090-4385hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
50090-4385hydroxyzine pamoatehydroxyzine pamoateA-S Medication SolutionsANDACurrent
53217-256HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEAidarex Pharmaceuticals LLCANDACurrent
53808-0886HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEState of Florida DOH Central PharmacyANDACurrent
55700-635HYDROXYZINE PAMOATEHYDROXYZINE PAMOATELake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-294HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEGolden State Medical Supply, Inc.ANDACurrent
60429-295HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEGolden State Medical Supply, Inc.ANDACurrent
60429-295HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEGolden State Medical Supply, Inc.ANDACurrent
60760-169HYDROXYZINE PAMOATEHYDROXYZINE PAMOATESt. Mary's Medical Park PharmacyANDACurrent
61919-121HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
61919-121HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
61919-121HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
61919-352HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
61919-352HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEDIRECT RXANDACurrent
63187-763HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEProficient Rx LPANDACurrent
63187-763HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEProficient Rx LPANDACurrent
63629-8183hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
63629-8183hydroxyzine pamoatehydroxyzine pamoateBryant Ranch PrepackANDACurrent
64725-0169HYDROXYZINE PAMOATEHYDROXYZINE PAMOATETYA PharmaceuticalsANDACurrent
64725-0170HYDROXYZINE PAMOATEHYDROXYZINE PAMOATETYA PharmaceuticalsANDACurrent
64725-1690HYDROXYZINE PAMOATEHYDROXYZINE PAMOATETYA PharmaceuticalsANDACurrent
64980-169HYDROXYZINE PAMOATEHYDROXYZINE PAMOATERising Pharmaceuticals Inc.ANDACurrent
64980-170HYDROXYZINE PAMOATEHYDROXYZINE PAMOATERising Pharmaceuticals Inc.ANDACurrent
66267-114HYDROXYZINE PAMOATEHYDROXYZINE PAMOATENuCare Pharmaceuticals, Inc.ANDACurrent
66267-114HYDROXYZINE PAMOATEHYDROXYZINE PAMOATENuCare Pharmaceuticals, Inc.ANDACurrent
67296-1098HYDROXYZINE PAMOATEHYDROXYZINE PAMOATERedPharm Drug, Inc.ANDACurrent
67296-1387HYDROXYZINE PAMOATEHYDROXYZINE PAMOATERedPharm Drug, Inc.ANDACurrent
67296-1719hydroxyzine pamoatehydroxyzine pamoateRedPharm Drug, Inc.ANDACurrent
67296-1719hydroxyzine pamoatehydroxyzine pamoateRedPharm Drug, Inc.ANDACurrent
68071-1054HYDROXYZINE PAMOATEHYDROXYZINE PAMOATENuCare Pharmaceuticals, Inc.ANDACurrent
68071-1811HYDROXYZINE PAMOATEHYDROXYZINE PAMOATENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2521hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4954hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4954hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5124hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5124hydroxyzine pamoatehydroxyzine pamoateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7214HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7214HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.ANDACurrent
68788-7767hydroxyzine pamoatehydroxyzine pamoatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7767hydroxyzine pamoatehydroxyzine pamoatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7767hydroxyzine pamoatehydroxyzine pamoatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9386HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9386HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1653HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEREMEDYREPACK INC.ANDACurrent
70518-1653HYDROXYZINE PAMOATEHYDROXYZINE PAMOATEREMEDYREPACK INC.ANDACurrent
70518-2296hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2296hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2296hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2296hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2350hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2350hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2350hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2350hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-2350hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-3452hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-3452hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
70518-3452hydroxyzine pamoatehydroxyzine pamoateREMEDYREPACK INC.ANDACurrent
71205-433hydroxyzine pamoatehydroxyzine pamoateProficient Rx LPANDACurrent

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