Application Nr Approved Date Route Status External Links
NDA020358 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Wellbutrin Sr (Bupropion Hydrochloride) Is Indicated For The Treatment Of Major Depressive Disorder (Mdd), As Defined By The Diagnostic And Statistical Manual (Dsm). The Efficacy Of Bupropion 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 )] . The Efficacy Of Wellbutrin Sr In Maintaining An Antidepressant Response For Up To 44 Weeks Following 8 Weeks Of Acute Treatment Was Demonstrated In A Placebo‑controlled Trial [See Clinical Studies ( 14 )] . Wellbutrin Sr Is An Aminoketone Antidepressant, Indicated For The Treatment Of Major Depressive Disorder (Mdd). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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