FDA.reportPublic FDA data

Application 088617

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDETABLET;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5060Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5060Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5060Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5060Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5060Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5060Hydroxyzine HydrochlorideHydroxyzine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-209HydroxyzineHydroxyzineBlenheim Pharmacal, Inc.ANDACurrent
50090-4117Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4117Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4117Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4117Hydroxyzine HydrochlorideHydroxyzine HydrochlorideA-S Medication SolutionsANDACurrent
60687-664Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Health PackagingANDACurrent
60760-285Hydroxyzine HydrochlorideHydroxyzine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
60760-285Hydroxyzine HydrochlorideHydroxyzine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
63629-8738Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8738Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
68071-4499Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4499Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4499Hydroxyzine HydrochlorideHydroxyzine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7676Hydroxyzine HydrochlorideHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70934-233Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-233Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-233Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-891Hydroxyzine HydrochlorideHydroxyzine HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0961Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0961Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0961Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0961Hydroxyzine HydrochlorideHydroxyzine HydrochlorideBryant Ranch PrepackANDACurrent
72789-271Hydroxyzine HydrochlorideHydroxyzine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18521SUPPL2014-06-24
31433SUPPL2014-06-11
18520SUPPL2014-04-18