FDA.reportPublic FDA data

Application 210137

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-0122FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-1220FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDESpirit Pharmaceuticals LLCANDACurrent
68210-4148FEXOFENADINE HClFEXOFENADINE HClSpirit Pharmaceuticals LLCANDACurrent
68210-4148FEXOFENADINE HClFEXOFENADINE HClSpirit Pharmaceuticals LLCANDACurrent
68210-4148FEXOFENADINE HClFEXOFENADINE HClSpirit Pharmaceuticals LLCANDACurrent
72476-121FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDERETAIL BUSINESS SERVICES, LLCANDACurrent
72476-126FEXOFENADINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDERETAIL BUSINESS SERVICES, LLCANDACurrent