FDA.reportPublic FDA data

Application 201546

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDESYRUP;ORAL5MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-2106Wal-ZyrCetirizine HydrochlorideWALGREEN COMPANYANDACurrent
11673-106up and upCetirizine HydrochlorideTarget CorporationANDACurrent
11822-2106Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-2106Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-2106Rite AidCetirizine HydrochlorideRite Aid CorporationANDACurrent
21130-106SafewayCetirizine HydrochlorideSafeway Inc.ANDACurrent
30142-106ChildrensCetirizine HydrochlorideKroger CompanyANDACurrent
37205-591Leader Childrens Allergy ReliefCetirizine HydrochlorideCardinal HealthANDACurrent
37808-106Allergy ReliefCetirizine HydrochlorideH E BANDACurrent
41250-106ChildrensCetirizine HydrochlorideMeijer Distribution IncANDACurrent
46122-101All DayCetirizine HydrochlorideAmerisource BergenANDACurrent
46122-101All DayCetirizine HydrochlorideAmerisource BergenANDACurrent
49035-106ChildrensCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49348-078ChildrensCetirizine HydrochlorideMcKessonANDACurrent
51672-2106Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2106Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2148CHILDRENS CETIRIZINE HYDROCHLORIDECetirizine HydrochlorideTARO PHARMACEUTICALS U.S.A., INC.ANDACurrent
52549-2106Cetirizine HydrochlorideCetirizine HydrochlorideTaro Pharmaceutical Industries, Ltd.ANDACurrent
55312-106Western FamilyCetirizine HydrochlorideWestern Family Foods IncANDACurrent
56062-106Childrens AllergyCetirizine HydrochloridePublix Super Markets IncANDACurrent
56062-106Childrens AllergyCetirizine HydrochloridePublix Super Markets IncANDACurrent
59779-106CVSCetirizine HydrochlorideCVS PharmacyANDACurrent
62011-0093Childrens Cetirizine HydrochlorideCetirizine hydrochlorideHealth MartANDACurrent
63868-106Quality ChoiceCetirizine HydrochlorideChain Drug Marketing AssociationANDACurrent
68016-106ChildrensCetirizine HydrochloridePharmacy Value Alliance LLCANDACurrent
70253-106Our FamilyCetirizine HydrochlorideNash Finch CompanyANDACurrent