FDA.reportPublic FDA data

Application 077284

Type
ANDA
Sponsor
ANCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7560BUDEPRION XLBUPROPION HYDROCHLORIDENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7915Bupropion HydrochlorideBupropion HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6573Bupropion HydrochlorideBupropion HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6573Bupropion HydrochlorideBupropion HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6573Bupropion HydrochlorideBupropion HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6573Bupropion HydrochlorideBupropion HydrochlorideMajor PharmaceuticalsANDACurrent
10370-101Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-101Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-101Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-101Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-101Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-102Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-102Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-102Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-102Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
10370-102Bupropion HydrochlorideBupropion HydrochloridePar Pharmaceutical, Inc.ANDACurrent
33261-627BUPROPION HYDROCHLORIDEbupropion hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-680BUPROPION HYDROCHLORIDEbupropion hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42291-182Bupropion HydrochlorideBupropion HydrochlorideAvKARE, Inc.ANDACurrent
42291-182Bupropion HydrochlorideBupropion HydrochlorideAvKAREANDACurrent
42291-183Bupropion HydrochlorideBupropion HydrochlorideAvKAREANDACurrent
42291-183Bupropion HydrochlorideBupropion HydrochlorideAvKARE, Inc.ANDACurrent
43063-387Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
43063-387Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-387Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-387Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-387Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-387Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-388Bupropion HydrochlorideBupropion HydrochloridePD-Rx Pharmaceuticals, InANDACurrent
50090-1059Bupropion HydrochlorideBupropion HydrochlorideA-S Medication SolutionsANDACurrent
50268-140Bupropion HydrochlorideBupropion HydrochlorideAvPAKANDACurrent
50268-140Bupropion HydrochlorideBupropion HydrochlorideAvPAKANDACurrent
50268-140Bupropion HydrochlorideBupropion HydrochlorideAvPAKANDACurrent
50268-141Bupropion HydrochlorideBupropion HydrochlorideAvPAKANDACurrent
50268-141Bupropion HydrochlorideBupropion HydrochlorideAvPAKANDACurrent
50268-141Bupropion HydrochlorideBupropion HydrochlorideAvPAKANDACurrent
55700-146Bupropion HydrochlorideBupropion HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-312Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
60687-312Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
60687-312Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
60687-312Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
61919-589BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirect_RxANDACurrent
61919-589BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirect_RxANDACurrent
61919-589BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirect_RxANDACurrent
61919-589BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirect_RxANDACurrent
61919-589BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEDirect RxANDACurrent
63187-124BUPROPION HYDROCHLORIDEbupropion hydrochlorideProficient Rx LPANDACurrent
63187-124BUPROPION HYDROCHLORIDEbupropion hydrochlorideProficient Rx LPANDACurrent
63629-2136Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2136Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2136Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2136Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2137Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2137Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2137Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2138Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2138Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2138Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2139Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2139Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-2139Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent
63629-3762BudeprionBupropion HydrochlorideBryant Ranch PrepackANDACurrent
67046-082Bupropion HydrochlorideBupropion HydrochlorideContract Pharmacy Services-PAANDACurrent
68084-252Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
68084-252Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
68084-252Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
68084-252Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
68084-252Bupropion HydrochlorideBupropion HydrochlorideAmerican Health PackagingANDACurrent
68788-7820Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7820Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9524Bupropion HydrochlorideBupropion HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-1437Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1437Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2365Bupropion HydrochlorideBupropion HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43118ORIG2012-03-28
39523ORIG2007-01-19
31216ORIG2006-12-28