FDA.reportPublic FDA data

Application 090385

Type
ANDA
Sponsor
GLENMARK GENERICS

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
50090-2061LEVOCETIRIZINE DIHYDROCHLORIDElevocetirizine dihydrochlorideA-S Medication SolutionsANDACurrent
63629-4492Levocetirizine Dihydrochloridelevocetirizine dihydrochlorideBryant Ranch PrepackANDACurrent
68462-346LEVOCETIRIZINE DIHYDROCHLORIDElevocetirizine dihydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-346LEVOCETIRIZINE DIHYDROCHLORIDElevocetirizine dihydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-346LEVOCETIRIZINE DIHYDROCHLORIDElevocetirizine dihydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-346LEVOCETIRIZINE DIHYDROCHLORIDElevocetirizine dihydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent