FDA.reportPublic FDA data

Application 210755

Type
ANDA
Sponsor
GUARDIAN DRUG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION/DROPS;ORAL40MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49035-635Concentrated ibuprofen infantsIbuprofenWal-Mart Stores, Inc.ANDACurrent
49035-635Concentrated ibuprofen infantsIbuprofenWal-Mart Stores, Inc.ANDACurrent
53041-637Concentrated ibuprofen infantsIbuprofenGuardian Drug CompanyANDACurrent
53041-637Concentrated ibuprofen infantsIbuprofenGuardian Drug CompanyANDACurrent