Application Nr Approved Date Route Status External Links
ANDA075491 2000-04-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bupropion Hydrochloride Tablets 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)]. Bupropion Hydrochloride Is An Aminoketone Antidepressant, Indicated For The Treatment Of Major Depressive Disorder (mdd). (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hydrochloric Acid HYDROCHLORIC ACID Unresolved B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Stearic Acid STEARIC ACID 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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