FDA.reportPublic FDA data

Application 088618

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL25MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5061Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-210HydroxyzineHydroxyzineBlenheim Pharmacal, Inc.ANDACurrent
50090-3286Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3286Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3362Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4404Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
53002-3200Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3200Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3900Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3900Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
60687-675Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Health PackagingANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-743HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEDIRECT RXANDACurrent
63629-7675Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8740Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8740Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
67296-0055Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug Inc.ANDACurrent
67296-1681Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1681Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-2229Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2229Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4530HydrOXYzine HydrochlorideHydrOXYzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4530HydrOXYzine HydrochlorideHydrOXYzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4530HydrOXYzine HydrochlorideHydrOXYzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7464Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7464Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7464Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2066Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2066Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2279Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-234Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-234Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-155Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0935Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-216Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18523SUPPL2014-06-24
31434SUPPL2014-06-11
18522SUPPL2014-04-18