Application Nr Approved Date Route Status External Links
ANDA079095 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 (Sr) Are 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 Bupropion 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 )] . Bupropion Hydrochloride Extended-Release Tablets (Sr) Are 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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