FDA.reportPublic FDA data

Application 040604

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL50MGNoNo
002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6617Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6617Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6617Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6618Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6618Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6618Hydroxyzine HydrochlorideHydroxyzine HydrochlorideMajor PharmaceuticalsANDACurrent
42806-161Hydroxyzine HydrochlorideHydroxyzine HydrochlorideEpic Pharma, LLCANDACurrent
42806-161Hydroxyzine HydrochlorideHydroxyzine HydrochlorideEpic Pharma, LLCANDACurrent
55154-7994Hydroxyzine HydrochlorideHydroxyzine HydrochlorideCardinal HealthANDACurrent
68071-5133Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5133Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2240Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3574Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-285Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-285Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-332Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-332Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-332Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71335-2185Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53937ORIG2018-05-01