FDA.reportPublic FDA data

Application 210149

Type
ANDA
Sponsor
GUARDIAN DRUG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53041-572Childrens Ibuprofen bubblegumIbuprofenGuardian Drug CompanyANDACurrent
53041-632Childrens Ibuprofen fruitIbuprofenGuardian Drug CompanyANDACurrent
53041-634Childrens IbuprofenIbuprofenGuardian Drug CompanyANDACurrent
53041-638Childrens Ibuprofen blue raspberryIbuprofenGuardian Drug CompanyANDACurrent
53041-639Childrens Ibuprofen grapeIbuprofenGuardian Drug CompanyANDACurrent