Application Nr Approved Date Route Status External Links
ANDA077285 2008-11-26 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 (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 (13 Total)

Name Structure Kind Function Status
1. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. 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.
4. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A Unresolved
9. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
10. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
11. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
12. Povidones POVIDONES Unresolved
13. Water WATER Molecular

Active Ingredients ( 1 Total)

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

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