Application 215568

Type
ANDA
Sponsor
GRANULES

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
70010-784Bupropion hydrochlorideBupropion hydrochlorideGranules Pharmaceuticals Inc.ANDACurrent
70010-785Bupropion hydrochlorideBupropion hydrochlorideGranules Pharmaceuticals Inc.ANDACurrent