FDA.reportPublic FDA data

Application 078933

Type
ANDA
Sponsor
MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25000-219Cetirizine Hydrochloride Tablets, 5 mgCetirizine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-220Cetirizine Hydrochloride Tablets, 10 mgCetirizine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
41226-692ALLERGYCETIRIZINE HYDROCHLORIDEKroger CompanyANDACurrent
41226-692ALLERGYCETIRIZINE HYDROCHLORIDEKroger CompanyANDACurrent
49483-682Cetirizine HydrochlorideCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-692Cetirizine Hydrochloride Tablets,10 mgCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-692Cetirizine Hydrochloride Tablets,10 mgCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-692Cetirizine Hydrochloride Tablets,10 mgCetirizine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent