FDA.reportPublic FDA data

Application 090325

Type
ANDA
Sponsor
MYLAN

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
0378-3411Bupropion hydrochlorideBupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3411Bupropion hydrochlorideBupropion hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3412Bupropion hydrochlorideBupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3412Bupropion hydrochlorideBupropion hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3413Bupropion hydrochlorideBupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3413Bupropion hydrochlorideBupropion hydrochlorideMylan Pharmaceuticals IncANDACurrent
51079-391Bupropion hydrochlorideBupropion hydrochlorideMylan Institutional Inc.ANDACurrent
51079-392Bupropion hydrochlorideBupropion hydrochlorideMylan Institutional Inc.ANDACurrent
55154-4392Bupropion hydrochlorideBupropion hydrochlorideCardinal Health, Inc.ANDACurrent
55154-4392Bupropion hydrochlorideBupropion hydrochlorideCardinal Health, Inc.ANDACurrent
71335-0783Bupropion hydrochlorideBupropion hydrochlorideBryant Ranch PrepackANDACurrent