FDA.report

Application 090142

Type
ANDA
Sponsor
SUN PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL5MGNoNo
002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL10MGNoNo
003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL5MGNoNo
004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDETABLET, CHEWABLE;ORAL10MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-343Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-343Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-343Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-343Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-344Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-344Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-344Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-344Cetirizine HydrochlorideCetirizine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
51660-066Cetirizine HydrochlorideCetirizine HydrochlorideOHM LABORATORIES INC.ANDACurrent
68016-353Cetirizine HydrochlorideCetirizine HydrochlorideChain Drug Consortium, LLCANDACurrent