FDA.reportPublic FDA data

Application 091264

Type
ANDA
Sponsor
HETERO LABS LTD III

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
31722-551Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-551Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
50090-1430Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
50090-1430Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
70518-0931Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0931Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0931Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0789Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent
71335-0789Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent
71335-0789Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent
72789-023Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-023Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-023Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-023Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-023Levocetirizine DihydrochlorideLevocetirizine DihydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent