FDA.reportPublic FDA data

Application 203027

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-831Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-831Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2591Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
50090-2591Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
53217-375Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideAidarex Pharmaceuticals LLCANDACurrent
60505-3713Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideApotex Corp.ANDACurrent
60505-3713Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideApotex Corp.ANDACurrent
60505-3713Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideApotex Corp.ANDACurrent
63187-922Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
63187-922Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideProficient Rx LPANDACurrent
68788-6892Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-0162Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent
71335-0162Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent