Application 202774

Type
ANDA
Sponsor
JUBILANT GENERICS

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
59746-315Bupropion Hydrochloridebupropion hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-315Bupropion Hydrochloridebupropion hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-316Bupropion Hydrochloridebupropion hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-316Bupropion Hydrochloridebupropion hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-317Bupropion Hydrochloridebupropion hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-317Bupropion Hydrochloridebupropion hydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent