Application 090356

Type
ANDA
Sponsor
SUN PHARM

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
0904-7036NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
0904-7036NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEMajor PharmaceuticalsANDACurrent
47335-326NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ANDACurrent
50090-3929NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
50090-3929NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEA-S Medication SolutionsANDACurrent
70518-2718NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2718NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2718NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
71335-2062NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEBryant Ranch PrepackANDACurrent