FDA.reportPublic FDA data

Application 201567

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63187-521bupropionbupropionProficient Rx LPANDACurrent
63187-521bupropionbupropionProficient Rx LPANDACurrent
63187-521bupropionbupropionProficient Rx LPANDACurrent
65841-780bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-780bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-780bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-780bupropionbupropionZydus Lifesciences LimitedANDACurrent
65841-780bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-836bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-836bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-836bupropionbupropionCadila Healthcare LimitedANDACurrent
65841-836bupropionbupropionZydus Lifesciences LimitedANDACurrent
65841-836bupropionbupropionCadila Healthcare LimitedANDACurrent
68001-264bupropionbupropionBluePoint LaboratoriesANDACurrent
68382-353bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-353bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-353bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-353bupropionbupropionZydus Pharmaceuticals USA Inc.ANDACurrent
68382-353bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-353bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-354bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-354bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-354bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-354bupropionbupropionZydus Pharmaceuticals USA Inc.ANDACurrent
68382-354bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-354bupropionbupropionZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-9255bupropionbupropionPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53551ORIG1900-01-01
53550ORIG1900-01-01
53548ORIG1900-01-01
53547ORIG1900-01-01
53545ORIG1900-01-01