FDA.reportPublic FDA data

Application 077415

Type
ANDA
Sponsor
IMPAX LABS

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
0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDEImpax GenericsANDACurrent
0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-6811Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
45865-632Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMedsource PharmaceuticalsANDACurrent
45865-632Bupropion HydrochlorideBUPROPION HYDROCHLORIDEMedsource PharmaceuticalsANDACurrent
55700-684Bupropion HydrochlorideBUPROPION HYDROCHLORIDELake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-713Bupropion HydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPANDACurrent
63187-713Bupropion HydrochlorideBUPROPION HYDROCHLORIDEProficient Rx LPANDACurrent
63629-7033Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-7033Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-7033Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch PrepackANDACurrent
68788-6800Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6800Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6800Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0349Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-0349Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
71335-1156Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1156Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1156Bupropion HydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43122SUPPL2013-05-14
22603SUPPL2013-05-14
43121ORIG2011-08-09
31235ORIG2007-02-23