FDA.reportPublic FDA data

Application 075491

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL75MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0433Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0433Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0435Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0435Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-7631Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7632Bupropion Hydrochloridebupropion hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-284Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-284Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-284Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-575Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-943Bupropion Hydrochloridebupropion hydrochlorideMylan Institutional Inc.ANDACurrent
51079-943Bupropion Hydrochloridebupropion hydrochlorideMylan Institutional Inc.ANDACurrent
51079-944Bupropion Hydrochloridebupropion hydrochlorideMylan Institutional Inc.ANDACurrent
51079-944Bupropion Hydrochloridebupropion hydrochlorideMylan Institutional Inc.ANDACurrent
52959-655Bupropion Hydrochloridebupropion hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53808-0214Bupropion Hydrochloridebupropion hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0347Bupropion Hydrochloridebupropion hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0908Bupropion Hydrochloridebupropion hydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0910Bupropion Hydrochloridebupropion hydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-4394Bupropion Hydrochloridebupropion hydrochlorideCardinal HealthANDACurrent
55154-4394Bupropion Hydrochloridebupropion hydrochlorideCardinal HealthANDACurrent
55289-733Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-733Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-733Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-733Bupropion Hydrochloridebupropion hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
67046-075Bupropion Hydrochloridebupropion hydrochlorideContract Pharmacy Services-PAANDACurrent
67046-076Bupropion Hydrochloridebupropion hydrochlorideContract Pharmacy Services-PAANDACurrent
67544-406Bupropion Hydrochloridebupropion hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
70518-0788Bupropion Hydrochloridebupropion hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44259ORIG2005-07-28
22475ORIG2003-07-30
8690ORIG2000-04-17