FDA.reportPublic FDA data

Application 212266

Type
ANDA
Sponsor
QUAGEN

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
70752-103CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLCANDACurrent
70752-103CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLCANDACurrent
70752-104CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLCANDACurrent
70752-104CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63195ORIG2020-05-20
63194ORIG2020-05-20