FDA.reportPublic FDA data

Application 211200

Type
ANDA
Sponsor
ZHEJIANG JUTAI PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL300MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-703Bupropion Hydrochloride Extended ReleaseBUPROPION HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-703Bupropion Hydrochloride Extended ReleaseBUPROPION HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-704Bupropion Hydrochloride Extended ReleaseBUPROPION HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
10135-704Bupropion Hydrochloride Extended ReleaseBUPROPION HYDROCHLORIDEMarlex Pharmaceuticals IncANDACurrent
52817-345buPROpion Hydrochloridebupropion hydrochlorideTruPharma LLCANDACurrent
52817-345buPROpion Hydrochloridebupropion hydrochlorideTruPharma LLCANDACurrent
52817-345buPROpion Hydrochloridebupropion hydrochlorideTruPharma LLCANDACurrent
52817-346buPROpion Hydrochloridebupropion hydrochlorideTruPharma LLCANDACurrent
52817-346buPROpion Hydrochloridebupropion hydrochlorideTruPharma LLCANDACurrent
52817-346buPROpion Hydrochloridebupropion hydrochlorideTruPharma LLCANDACurrent
71610-543Bupropion Hydrochloride Extended ReleaseBUPROPION HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71765-002buPropion Hydrochloridebupropion hydrochlorideZhejiang Jutai Pharamceutical Co., LtdANDACurrent
71765-002buPropion Hydrochloridebupropion hydrochlorideZhejiang Jutai Pharamceutical Co., LtdANDACurrent