FDA.reportPublic FDA data

Application 078420

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-111NabumetoneNabumetoneMedsource PharmaceuticalsANDACurrent
50090-5294NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-5294NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-5294NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50090-6167NabumetoneNabumetoneA-S Medication SolutionsANDACurrent
50228-465NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-465NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-465NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-465NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-465NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-466NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-466NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-466NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-466NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
50228-466NabumetoneNabumetoneScieGen Pharmaceuticals IncANDACurrent
53002-6960NabumetoneNabumetoneRPK Pharmaceuticals, Inc.ANDACurrent
55700-840NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-840NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-840NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-845NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-845NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
55700-845NabumetoneNabumetoneQuality Care Products, LLCANDACurrent
60760-368NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-368NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-369NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-369NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
60760-369NabumetoneNabumetoneSt. Mary's Medical Park PharmacyANDACurrent
63629-8506NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8506NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8506NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8508NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8508NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8508NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8509NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8509NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8509NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8510NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8510NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
63629-8510NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
68071-5166NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5166NabumetoneNabumetoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7597NabumetoneNabumetonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7597NabumetoneNabumetonePreferred Pharmaceuticals Inc.ANDACurrent
68788-7765NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7765NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7765NabumetoneNabumetonePreferred Pharmaceuticals, Inc.ANDACurrent
69367-241NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-241NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-241NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-241NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-242NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-242NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-242NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
69367-242NabumetoneNabumetoneWestminster Pharmaceuticals, LLCANDACurrent
70934-847NabumetoneNabumetoneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-530NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-530NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-977NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-977NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-977NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-978NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-978NabumetoneNabumetoneProficient Rx LPANDACurrent
71205-978NabumetoneNabumetoneProficient Rx LPANDACurrent
71335-1391NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1391NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1391NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1559NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
71335-1559NabumetoneNabumetoneBryant Ranch PrepackANDACurrent
72189-072NABUMETONENABUMETONEdirect rxANDACurrent
72189-072NABUMETONENABUMETONEdirect rxANDACurrent
72189-072NABUMETONENABUMETONEdirect rxANDACurrent
72189-072NABUMETONENABUMETONEdirect rxANDACurrent
72189-072NABUMETONENABUMETONEdirect rxANDACurrent
72189-072NABUMETONENABUMETONEdirect rxANDACurrent
72189-184NABUMETONENABUMETONEdirect rxANDACurrent
72189-184NABUMETONENABUMETONEdirect rxANDACurrent
72189-184NABUMETONENABUMETONEdirect rxANDACurrent
72189-184NABUMETONENABUMETONEdirect rxANDACurrent
72189-184NABUMETONENABUMETONEdirect rxANDACurrent
72789-040NabumetoneNabumetonePD-Rx Pharmaceuticals, Inc.ANDACurrent