FDA.reportPublic FDA data

Application 213513

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
50090-5341Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
50090-5341Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideA-S Medication SolutionsANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer CareANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer Care IncANDACurrent
69230-321Levocetirizine DihydrochlorideLevocetirizine DihydrochlorideCamber Consumer CareANDACurrent
73581-201ALLERGY RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEYYBA CORPANDACurrent