FDA.reportPublic FDA data

Application 202046

Type
ANDA
Sponsor
MICRO LABS LTD INDIA

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
10135-639Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideMarlex Pharmaceuticals IncANDACurrent
42571-122Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideMicro Labs LimitedANDACurrent
42571-122Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideMicro Labs LimitedANDACurrent
42571-122Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideMicro Labs LimitedANDACurrent
42571-122Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideMicro Labs LimitedANDACurrent
68071-5107Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5107Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7699Levocetirizine Dihydrochloridelevocetirizine DihydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7699Levocetirizine Dihydrochloridelevocetirizine DihydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7699Levocetirizine Dihydrochloridelevocetirizine DihydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2797Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2797Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideREMEDYREPACK INC.ANDACurrent
71205-210Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71205-210Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71205-210Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideProficient Rx LPANDACurrent
71335-1305Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent
71335-1305Levocetirizine Dihydrochloridelevocetirizine DihydrochlorideBryant Ranch PrepackANDACurrent