FDA.reportPublic FDA data

Application 205794

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL100MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo
003BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-536Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-536Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-536Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-537Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-537Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-537Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-538Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-538Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-538Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-751Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-751Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-751Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-751Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-751Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-752Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-752Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-752Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-752Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-752Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-753Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-753Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-753Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-753Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
43598-753Bupropion Hydrochloridebupropion hydrochlorideDr. ReddyANDACurrent
50228-174Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-174Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-174Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-174Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-174Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-175Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-175Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-175Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-175Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-175Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-176Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-176Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-176Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-176Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
50228-176Bupropion Hydrochloridebupropion hydrochlorideScieGen Pharmaceuticals, Inc.ANDACurrent
63629-8473Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
63629-8473Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
68071-1573Bupropion Hydrochloridebupropion hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2890Bupropion Hydrochloridebupropion hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2890Bupropion Hydrochloridebupropion hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7174Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7174Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7174Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7793Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7793Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7793Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7807Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7807Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7807Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7819Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7819Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7819Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70934-791Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-791Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-791Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-928Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-550Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
71205-550Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
71335-1702Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1702Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1702Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1866Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1866Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1984Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1984Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71610-570Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-576Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-576Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-582Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-582Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-349BUPROPION HYDROCHLORIDE SRBUPROPION HYDROCHLORIDE SRDirectRxANDACurrent
72189-349BUPROPION HYDROCHLORIDE SRBUPROPION HYDROCHLORIDE SRDirectRxANDACurrent
72789-158Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-158Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
77771-174Bupropion Hydrochloridebupropion hydrochlorideRadha Pharmaceuticals, Inc.ANDACurrent
77771-175Bupropion Hydrochloridebupropion hydrochlorideRadha Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10503ORIG2016-03-03