FDA.reportPublic FDA data

Application 075274

Type
ANDA
Sponsor
ELITE LABS

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
42291-632Naltrexone HydrochlorideNaltrexone HydrochlorideAvKAREANDACurrent
42291-632Naltrexone HydrochlorideNaltrexone HydrochlorideAvKARE, Inc.ANDACurrent
50090-2866Naltrexone HydrochlorideNaltrexone HydrochlorideA-S Medication SolutionsANDACurrent
50090-2866Naltrexone HydrochlorideNaltrexone HydrochlorideA-S Medication SolutionsANDACurrent
50090-3076Naltrexone HydrochlorideNaltrexone HydrochlorideA-S Medication SolutionsANDACurrent
51224-206Naltrexone HydrochlorideNaltrexone HydrochlorideTAGI Pharma Inc.ANDACurrent
51224-206Naltrexone HydrochlorideNaltrexone HydrochlorideTAGI Pharma Inc.ANDACurrent
53217-261Naltrexone HydrochlorideNaltrexone HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
63629-1046Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1046Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1046Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1046Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1047Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1047Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
63629-1047Naltrexone HydrochlorideNaltrexone HydrochlorideBryant Ranch PrepackANDACurrent
68071-2156Naltrexone HydrochlorideNaltrexone HydrochlorideNuCare Pharmaceuticls, Inc.ANDACurrent
68071-2156Naltrexone HydrochlorideNaltrexone HydrochlorideNuCare Pharmaceuticls, Inc.ANDACurrent
68094-853Naltrexone Hydrochloridenaltrexone HydrochloridePrecision Dose Inc.ANDACurrent
68094-853Naltrexone Hydrochloridenaltrexone HydrochloridePrecision Dose Inc.ANDACurrent
68094-853Naltrexone Hydrochloridenaltrexone HydrochloridePrecision Dose Inc.ANDACurrent
76519-1160NALTREXONE HYDROCHLORIDENALTREXONE HYDROCHLORIDEH.J. Harkins Company Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22452ORIG1999-05-26
8593ORIG1999-05-26