FDA.reportPublic FDA data

Application 076601

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5220Cetirizine HydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
51672-4070Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
71205-435Cetirizine HydrochlorideCetirizine HydrochlorideProficient Rx LPANDACurrent