Application 085910

Type
ANDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE 2.5/APAP 500ACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL500MG;2.5MGNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085910-001OXYCODONE 2.5/APAP 500ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE500MG;2.5MGTABLET / ORALApproved before 1982