FDA.reportPublic FDA data

Application 088619

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5062Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5062Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5062Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5062Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5062Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5062Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
55700-760Hydroxyzine HydrochlorideHydroxyzine HydrochlorideQuality Care Products, LLCANDACurrent
55700-760Hydroxyzine HydrochlorideHydroxyzine HydrochlorideQuality Care Products, LLCANDACurrent
55700-760Hydroxyzine HydrochlorideHydroxyzine HydrochlorideQuality Care Products, LLCANDACurrent
55700-760Hydroxyzine HydrochlorideHydroxyzine HydrochlorideQuality Care Products, LLCANDACurrent
60687-686Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Health PackagingANDACurrent
68071-4748Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4748Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2154Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2154Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2159Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2159Hydroxyzine HydrochlorideHydroxyzine HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-258Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-258Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-083Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-083Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-083Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71205-083Hydroxyzine HydrochlorideHydroxyzine HydrochlorideProficient Rx LPANDACurrent
71335-0246Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0246Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0246Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
72789-269Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
80425-0173Hydroxyzine HCLHydroxyzine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0173Hydroxyzine HCLHydroxyzine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18525SUPPL2014-06-24
31435SUPPL2014-06-11
18524SUPPL2014-04-18