Application Nr Approved Date Route Status External Links
ANDA076565 2010-06-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Venlafaxine Hydrochloride Extended-Release Capsules Are A Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For The Treatment Of: •major Depressive Disorder (mdd) •generalized Anxiety Disorder (gad) •social Anxiety Disorder (sad) •panic Disorder (pd) 1.1 Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Capsules Are Indicated For The Treatment Of Major Depressive Disorder (mdd). Efficacy Was Established In Three Short-Term (4, 8, And 12 Weeks) And Two Long-Term, Maintenance Trials. 1.2 Generalized Anxiety Disorder Venlafaxine Hydrochloride Extended-Release Capsules Are Indicated For The Treatment Of Generalized Anxiety Disorder (gad). Efficacy Was Established In Two 8-Week And Two 26-Week Placebo-Controlled Trials. 1.3 Social Anxiety Disorder Venlafaxine Hydrochloride Extended-Release Capsules Are Indicated For The Treatment Of Social Anxiety Disorder (sad), Also Known As Social Phobia. Efficacy Was Established In Four 12-Week And One 26-Week, Placebo-Controlled Trials. 1.4 Panic Disorder Venlafaxine Hydrochloride Extended-Release Capsules Are Indicated For The Treatment Of Panic Disorder (pd), With Or Without Agoraphobia. Efficacy Was Established In Two 12-Week Placebo-Controlled Trials.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Dibutyl Sebacate DIBUTYL SEBACATE Molecular
2. Ethylcelluloses ETHYLCELLULOSES Unresolved
3. Gelatin GELATIN Unresolved
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Povidones POVIDONES Unresolved
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Venlafaxine Hydrochloride VENLAFAXINE HYDROCHLORIDE ZINC896698

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