FDA.reportPublic FDA data

Application 210622

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4741CHILDRENS ALLERGY RELIEFcetirizine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4741CHILDRENS ALLERGY RELIEFcetirizine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4741CHILDRENS ALLERGY RELIEFcetirizine hydrochlorideA-S Medication SolutionsANDACurrent
69230-316CHILDRENS ALLERGY RELIEFcetirizine hydrochlorideCamber Consumer CareANDACurrent
70677-0149CHILDRENS ALLERGY RELIEFcetirizine hydrochlorideStrategic Sourcing ServicesANDACurrent