Application Nr Approved Date Route Status External Links
ANDA090693 2017-04-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bupropion Hydrochloride Extended-Release Tablet (xl) Is An Aminoketone Antidepressant, Indicated For The Treatment Of Major Depressive Disorder (mdd) And Prevention Of Seasonal Affective Disorder (sad). Periodically Reevaluate Long-Term Usefulness For The Individual Patient. (1) 1.1 Major Depressive Disorder Bupropion Hydrochloride Extended-Release Tablets (xl) Are Indicated For The Treatment Of Major Depressive Disorder (mdd), As Defined By The Diagnostic And Statistical Manual (dsm). The Efficacy Of The Immediate-Release Formulation Of Bupropion Was Established In Two 4-Week Controlled Inpatient Trials And One 6-Week Controlled Outpatient Trial Of Adult Patients With Mdd. The Efficacy Of The Sustained-Release Formulation Of Bupropion In The Maintenance Treatment Of Mdd Was Established In A Long-Term (up To 44 Weeks), Placebo-Controlled Trial In Patients Who Had Responded To Bupropion In An 8-Week Study Of Acute Treatment [see Clinical Studies (14.1)]. 1.2 Seasonal Affective Disorder Bupropion Hydrochloride Extended-Release Tablets (xl) Are Indicated For The Prevention Of Seasonal Major Depressive Episodes In Patients With A Diagnosis Of Seasonal Affective Disorder (sad). The Efficacy Of Bupropion Hydrochloride Extended-Release Tablets (xl) In The Prevention Of Seasonal Major Depressive Episodes Was Established In 3 Placebo-Controlled Trials In Adult Outpatients With A History Of Mdd With An Autumn-Winter Seasonal Pattern As Defined In The Dsm [see Clinical Studies (14.2)].

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Dibutyl Sebacate DIBUTYL SEBACATE Molecular
4. Ethylcelluloses ETHYLCELLULOSES Unresolved
5. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
6. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
7. Cysteine Hydrochloride CYSTEINE HYDROCHLORIDE Molecular
8. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
9. Povidones POVIDONES Unresolved
10. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Bupropion Hydrochloride BUPROPION HYDROCHLORIDE ZINC20228

Comments