FDA.reportPublic FDA data

Application 079095

Type
ANDA
Sponsor
ACTAVIS LABS FL 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
0591-3540Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3540Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3540Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3540Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3541Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3541Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3541Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3541Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3542Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3542Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3542Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0591-3542Bupropion Hydrochloridebupropion hydrochlorideActavis Pharma, Inc.ANDACurrent
0615-6553BuPROPion HydrochlorideBuPROPion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6561BuPROPion HydrochlorideBuPROPion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-019BuPROPion HydrochlorideBuPROPion HydrochlorideRebel Distributors Corp.ANDACurrent
21695-020BuPROPion HydrochlorideBuPROPion HydrochlorideRebel Distributors Corp.ANDACurrent
21695-295BuPROPion HydrochlorideBuPROPion HydrochlorideRebel Distributors Corp.ANDACurrent
42254-185BuPROPion HydrochlorideBuPROPion HydrochlorideRebel Distributors CorpANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-913Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-538BuPROPion HydrochlorideBuPROPion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-546BuPROPion HydrochlorideBuPROPion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-900BuPROPion HydrochlorideBuPROPion HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-885Bupropion Hydrochloridebupropion hydrochloridemedsource pharmaceuticalsANDACurrent
50090-0861Bupropion Hydrochloridebupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-0861Bupropion Hydrochloridebupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-2584Bupropion Hydrochloridebupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-2584Bupropion Hydrochloridebupropion hydrochlorideA-S Medication SolutionsANDACurrent
50436-3541Bupropion Hydrochloridebupropion hydrochlorideUnit Dose ServicesANDACurrent
52959-806BuPROPion HydrochlorideBuPROPion HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53002-1345Bupropion Hydrochloridebupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1345Bupropion Hydrochloridebupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2509Bupropion Hydrochloridebupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55700-028Bupropion Hydrochloridebupropion hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-028Bupropion Hydrochloridebupropion hydrochlorideLake Erie Medical DBA QuaANDACurrent
60429-216Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-216Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-217Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-217Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-217Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-218Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-218Bupropion Hydrochloridebupropion hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63187-566Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-566Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-726Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-726Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-726Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-726Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-952Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63187-952Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
63629-6438Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
63629-6438Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
68071-2192Bupropion Hydrochloridebupropion hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68084-697BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-697BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-697BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-697BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-697BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-708Bupropion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-708Bupropion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-708BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-708BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
68084-708BuPROPion Hydrochloridebupropion hydrochlorideAmerican Health PackagingANDACurrent
70518-2029Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2297Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-225Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-225Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-277Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-277Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-277Bupropion Hydrochloridebupropion hydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0135Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0135Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0135Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0135Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent