FDA.reportPublic FDA data

Application 090474

Type
ANDA
Sponsor
TORRENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6372Cetrizine HydrochlorideCETIRIZINE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
11673-178Childrens Allergy ReliefCetirizine HClTARGET CorporationANDACurrent
11673-178Childrens Allergy ReliefCetirizine HClTARGET CorporationANDACurrent
55910-878Childrens AllergyCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-878Childrens AllergyCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-878Childrens AllergyCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-878Childrens AllergyCetirizine HClDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
63868-430Childrens AllergyCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-430Childrens AllergyCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-430Childrens AllergyCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
72828-178Allergo Kids PLUSCetirizine HClPlus Distributors LLCANDACurrent