FDA.reportPublic FDA data

Application 201674

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESYRUP;ORAL10MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0507Hydroxyzine HydrochlorideHydroxyzine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0507Hydroxyzine HydrochlorideHydroxyzine HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
54838-502Hydroxyzine HydrochlorideHydroxyzine HydrochlorideLannett Company, Inc.ANDACurrent
54838-502Hydroxyzine HydrochlorideHydroxyzine HydrochlorideLannett Company, Inc.ANDACurrent
54838-502Hydroxyzine HydrochlorideHydroxyzine HydrochlorideLannett Company, Inc.ANDACurrent
54838-502Hydroxyzine HydrochlorideHydroxyzine HydrochlorideLannett Company, Inc.ANDACurrent
62135-502Hydroxyzine HydrochlorideHydroxyzine HydrochlorideChartwell RX, LLCANDACurrent
68788-9466HydroxyzineHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9466HydroxyzineHydroxyzine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent