FDA.reportPublic FDA data

Application 022497

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORFIVO XLBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL450MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-637bupropion hydrochloridebupropion hydrochlorideAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-637bupropion hydrochloridebupropion hydrochlorideAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-637bupropion hydrochloridebupropion hydrochlorideAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-637bupropion hydrochloridebupropion hydrochlorideAlvogen Inc.NDA AUTHORIZED GENERICCurrent
49909-010Forfivobupropion hydrochlorideEdgemont Pharmaceuticals, LLCNDACurrent
52427-575Forfivobupropion hydrochlorideAlmatica Pharma Inc.NDACurrent
52427-575Forfivobupropion hydrochlorideAlmatica Pharma Inc.NDACurrent
52427-575Forfivobupropion hydrochlorideAlmatica Pharma Inc.NDACurrent
52427-575Forfivobupropion hydrochlorideAlmatica Pharma Inc.NDACurrent
52427-575Forfivobupropion hydrochlorideAlmatica Pharma Inc.NDACurrent
64679-830BUPROPION HYDROCHLORIDEbupropion hydrochlorideWockhardt USA LLC.NDA AUTHORIZED GENERICCurrent
64679-830BUPROPION HYDROCHLORIDEbupropion hydrochlorideWockhardt USA LLC.NDA AUTHORIZED GENERICCurrent
64679-830BUPROPION HYDROCHLORIDEbupropion hydrochlorideWockhardt USA LLC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84095SUPPL 2025-11-06
84094SUPPL 2025-11-06
84087SUPPL 2025-11-06
78433SUPPL 2024-05-08
78415SUPPL 2024-05-07
61239SUPPL2019-12-11
61238SUPPL2019-12-11
61229SUPPL2019-12-11
48302SUPPL2017-05-09
48262SUPPL2017-05-08
48261SUPPL2017-05-08
45218SUPPL2016-08-30
17645SUPPL2014-07-22
29782SUPPL2014-07-21
42537ORIG2012-07-06
24323ORIG2012-07-06
29781ORIG2011-11-17
38765ORIG2011-11-16