FDA.reportPublic FDA data

Application 090750

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55315-354CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-354CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideFred's, Inc.ANDACurrent
55315-354CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideFred's, Inc.ANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-028Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-030Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-422Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
58602-424Childrens Allergy ReliefCetirizine HydrochlorideAurohealth LLCANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
63868-865CHILDRENS ALLERGY RELIEFCetirizine HydrochlorideC.D.M.A., Inc.ANDACurrent
65862-422Childrens Cetirizine Hydrochloride AllergyCetirizine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-443Childrens Cetirizine Hydrochloride Hives ReliefCetirizine HydrochlorideAurobindo Pharma LimitedANDACurrent