FDA.reportPublic FDA data

Application 090765

Type
ANDA
Sponsor
AMNEAL PHARMS

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
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-003Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals LLCANDACurrent
65162-005Cetirizine HydrochlorideCetirizineAmneal Pharmaceuticals of New York, LLCANDACurrent