FDA.reportPublic FDA data

Application 207459

Type
ANDA
Sponsor
JUBILANT GENERICS

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
59746-314Bupropion hydrochlorideBupropion hydrochloride extended-release tablets (XL)Jubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-314Bupropion hydrochlorideBupropion hydrochloride extended-release tablets (XL)Jubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-758Bupropion hydrochlorideBupropion hydrochloride extended-release tablets (XL)Jubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-758Bupropion hydrochlorideBupropion hydrochloride extended-release tablets (XL)Jubilant Cadista Pharmaceuticals Inc.ANDACurrent