FDA.reportPublic FDA data

Application 206556

Type
ANDA
Sponsor
INVAGEN 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
0615-8179Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8179Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8241Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8241Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
61919-069BUPROPION HYDROCHLORIDE (XL)BUPROPION HYDROCHLORIDE (XL)DIRECT RXANDACurrent
61919-069BUPROPION HYDROCHLORIDE (XL)BUPROPION HYDROCHLORIDE (XL)DIRECT RXANDACurrent
67046-081Bupropion Hydrochloridebupropion hydrochlorideContract Pharmacy Services-PAANDACurrent
68001-321Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-321Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-321Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-321Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-322Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-322Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-322Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68001-322Bupropion Hydrochloridebupropion hydrochlorideBluePoint LaboratoriesANDACurrent
68788-6809Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6809Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6931Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6931Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7756Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7756Bupropion Hydrochloridebupropion hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69097-875Bupropion Hydrochloridebupropion hydrochlorideCIPLA USA INC.,ANDACurrent
69097-875Bupropion Hydrochloridebupropion hydrochlorideCIPLA USA INC.,ANDACurrent
69097-876Bupropion Hydrochloridebupropion hydrochlorideCIPLA USA INC.,ANDACurrent
69097-876Bupropion Hydrochloridebupropion hydrochlorideCIPLA USA INC.,ANDACurrent
70518-0436Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
71205-076Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
71205-076Bupropion Hydrochloridebupropion hydrochlorideProficient Rx LPANDACurrent
71335-0313Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0313Bupropion Hydrochloridebupropion hydrochlorideBryant Ranch PrepackANDACurrent
76282-480Bupropion Hydrochloridebupropion hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-480Bupropion Hydrochloridebupropion hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-480Bupropion Hydrochloridebupropion hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-481Bupropion Hydrochloridebupropion hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-481Bupropion Hydrochloridebupropion hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76282-481Bupropion Hydrochloridebupropion hydrochlorideExelan Pharmaceuticals Inc.ANDACurrent
76519-1021BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEH.J. Harkins Company Inc.ANDACurrent