FDA.reportPublic FDA data

Application 209107

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo
002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0068Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-0068Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-0068Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
0363-0068Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideWALGREEN CO.ANDACurrent
11822-4228Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideRITE AID CORPORATIONANDACurrent
30142-169Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideKROGER COMPANYANDACurrent
58602-716Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-806Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-806Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-806Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-808Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-808Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-808Cetirizine Hydrochloride (Hives Relief)Cetirizine HydrochlorideAurohealth LLCANDACurrent
58602-863Cetirizine Hydrochloride (Allergy)Cetirizine HydrochlorideAurohealth LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55185ORIG2018-08-16