FDA.reportPublic FDA data

Application 088108

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0709METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0709METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0709METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0709METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.ANDACurrent