FDA.reportPublic FDA data

Application 208652

Type
ANDA
Sponsor
SINOTHERAPEUTICS INC

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
0527-2415Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0527-2415Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0527-2430Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0527-2430Bupropion hydrochloride (XL)Bupropion hydrochlorideLannett Company Inc.ANDACurrent
0781-5528Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5528Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5528Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5529Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5529Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
0781-5529Bupropion hydrochloride (XL)Bupropion hydrochlorideSandoz Inc.ANDACurrent
50090-4169Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-4169Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-6173Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-6173Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
50090-6258Bupropion hydrochloride (XL)Bupropion hydrochlorideA-S Medication SolutionsANDACurrent
53002-1508Bupropion hydrochloride (XL)Bupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-1508Bupropion hydrochloride (XL)Bupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-2495Bupropion hydrochloride (XL)Bupropion hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
68788-7347Bupropion hydrochloride (XL)Bupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7347Bupropion hydrochloride (XL)Bupropion hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1229Bupropion hydrochloride (XL)Bupropion hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-723Bupropion hydrochloride (XL)Bupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-724Bupropion hydrochloride (XL)Bupropion hydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-045Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-045Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-248Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-248Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71205-248Bupropion hydrochloride (XL)Bupropion hydrochlorideProficient Rx LPANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-0824Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1542Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent
71335-1542Bupropion hydrochloride (XL)Bupropion hydrochlorideBryant Ranch PrepackANDACurrent