FDA.reportPublic FDA data

Application 090942

Type
ANDA
Sponsor
MYLAN

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
0378-2008Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2008Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2008Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2009Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2009Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2009Bupropion Hydrochloridebupropion hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
51079-047Bupropion Hydrochloridebupropion hydrochlorideMylan Institutional Inc.ANDACurrent
51079-109Bupropion Hydrochloridebupropion hydrochlorideMylan Institutional Inc.ANDACurrent