Application 207905

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-242Naltrexone HydrochlorideNaltrexone HydrochlorideChartwell RX, LLCANDACurrent
62135-242Naltrexone HydrochlorideNaltrexone HydrochlorideChartwell RX, LLCANDACurrent