Application Nr Approved Date Route Status External Links
ANDA203013 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bupropion Hydrochloride Tablets Usp Are Indicated For The Treatment Of Major Depressive Disorder (Mdd), As Defined By The Diagnostic And Statistical Manual (Dsm). The Efficacy Of Bupropion Hydrochloride Tablets Usp In The Treatment Of A Major Depressive Episode Was Established In Two 4-Week Controlled Inpatient Trials And One 6-Week Controlled Outpatient Trial Of Adult Subjects With Mdd [See Clinical Studies (14)] . Bupropion Hydrochloride Tablets Usp Are An A Mi N O K Et One A N Ti D E P R E Ssa N T, I N D Ic At Ed F Or T He T R Eat M E Nt Of Maj Or D E P R E Ssi Ve Di S O R D Er (M Dd) (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments