FDA.reportPublic FDA data

Application 087408

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/MLNoYes
002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9877Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9877Hydroxyzine HydrochlorideHydroxyzine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9878HydroxyzineHydroxyzineHenry Schein, Inc.ANDACurrent
0404-9878HydroxyzineHydroxyzineHenry Schein, Inc.ANDACurrent
0517-4201Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-4201Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-4201Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5601Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5601Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5601Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5602Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5602Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
0517-5602Hydroxyzine HydrochlorideHydroxyzine HydrochlorideAmerican Regent, Inc.ANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-007HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-601HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-601HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-601HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-610HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-610HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent
52584-610HydroxyzineHydroxyzineGeneral Injectables & Vaccines, IncANDACurrent