Application Nr Approved Date Route Status External Links
ANDA210497 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bupropion Hydrochloride Extended-Release Tablets (xl) Are 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments