FDA.reportPublic FDA data

Application 089160

Type
ANDA
Sponsor
MALLINCKRODT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANEXSIAACETAMINOPHEN; HYDROCODONE BITARTRATETABLET;ORAL500MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-407HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENMedsource PharmaceuticalsANDACurrent
67046-926HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENContract Pharmacy Services-PAANDACurrent