FDA.reportPublic FDA data

Application 040808

Type
ANDA
Sponsor
AMNEAL PHARM

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-226Hydroxyzine HydrochlorideHydroxyzineBlenheim Pharmacal, Inc.ANDACurrent
10544-227Hydroxyzine HydrochlorideHydroxyzineBlenheim Pharmacal, Inc.ANDACurrent
43063-435Hydroxyzine HydrochlorideHydroxyzinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-435Hydroxyzine HydrochlorideHydroxyzinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-912Hydroxyzine HydrochlorideHydroxyzinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-912Hydroxyzine HydrochlorideHydroxyzinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-912Hydroxyzine HydrochlorideHydroxyzinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-912Hydroxyzine HydrochlorideHydroxyzinePD-Rx Pharmaceuticals, Inc.ANDACurrent
60429-223Hydroxyzine HydrochlorideHydroxyzineGolden State Medical SupplyANDACurrent
60429-223Hydroxyzine HydrochlorideHydroxyzineGolden State Medical SupplyANDACurrent
60429-223Hydroxyzine HydrochlorideHydroxyzineGolden State Medical Supply, Inc.ANDACurrent
60429-223Hydroxyzine HydrochlorideHydroxyzineGolden State Medical Supply, Inc.ANDACurrent
60429-224Hydroxyzine HydrochlorideHydroxyzineGolden State Medical Supply, Inc.ANDACurrent
60429-224Hydroxyzine HydrochlorideHydroxyzineGolden State Medical Supply, Inc.ANDACurrent
60429-224Hydroxyzine HydrochlorideHydroxyzineGolden State Medical SupplyANDACurrent
60429-224Hydroxyzine HydrochlorideHydroxyzineGolden State Medical SupplyANDACurrent
60429-225Hydroxyzine HydrochlorideHydroxyzineGolden State Medical Supply, Inc.ANDACurrent
60429-225Hydroxyzine HydrochlorideHydroxyzineGolden State Medical Supply, Inc.ANDACurrent
60429-225Hydroxyzine HydrochlorideHydroxyzineGolden State Medical SupplyANDACurrent
60429-225Hydroxyzine HydrochlorideHydroxyzineGolden State Medical SupplyANDACurrent
63187-492Hydroxyzine HydrochlorideHydroxyzineProficient Rx LPANDACurrent
63187-492Hydroxyzine HydrochlorideHydroxyzineProficient Rx LPANDACurrent
63629-6716Hydroxyzine HydrochlorideHydroxyzineBryant Ranch PrepackANDACurrent
63629-6716Hydroxyzine HydrochlorideHydroxyzineBryant Ranch PrepackANDACurrent
65162-575Hydroxyzine HydrochlorideHydroxyzineAmneal Pharmaceuticals LLCANDACurrent
65162-575Hydroxyzine HydrochlorideHydroxyzineAmneal Pharmaceuticals LLCANDACurrent
65162-577Hydroxyzine HydrochlorideHydroxyzineAmneal Pharmaceuticals LLCANDACurrent
65162-577Hydroxyzine HydrochlorideHydroxyzineAmneal Pharmaceuticals LLCANDACurrent
65162-671Hydroxyzine HydrochlorideHydroxyzineAmneal Pharmaceuticals LLCANDACurrent
65162-671Hydroxyzine HydrochlorideHydroxyzineAmneal Pharmaceuticals LLCANDACurrent
67296-1293Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1293Hydroxyzine HydrochlorideHydroxyzine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67405-575Hydroxyzine HydrochlorideHydroxyzineHARRIS Pharmaceutical, Inc.ANDACurrent
67405-575Hydroxyzine HydrochlorideHydroxyzineHARRIS Pharmaceutical, Inc.ANDACurrent
67405-577Hydroxyzine HydrochlorideHydroxyzineHARRIS Pharmaceutical, Inc.ANDACurrent
67405-577Hydroxyzine HydrochlorideHydroxyzineHARRIS Pharmaceutical, Inc.ANDACurrent
67405-671Hydroxyzine HydrochlorideHydroxyzineHARRIS Pharmaceutical, Inc.ANDACurrent
67405-671Hydroxyzine HydrochlorideHydroxyzineHARRIS Pharmaceutical, Inc.ANDACurrent
71335-0986Hydroxyzine HydrochlorideHydroxyzineBryant Ranch PrepackANDACurrent
71335-0986Hydroxyzine HydrochlorideHydroxyzineBryant Ranch PrepackANDACurrent