Application Nr Approved Date Route Status External Links
ANDA202189 2012-11-21 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 Tablets (xl) Are 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 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 (14 Total)

Name Structure Kind Function Status
1. Ammonium Chloride AMMONIUM CHLORIDE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
6. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
10. Povidones POVIDONES Unresolved
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
13. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
14. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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