Application Nr Approved Date Route Status External Links
NDA022104 2008-05-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Venlafaxine Extended Release Tablets Are A Selective Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For: Major Depressive Disorder (mdd) (1.1) Social Anxiety Disorder (sad) (1.2) 1.1 Major Depressive Disorder Venlafaxine Extended Release Tablets (venlafaxine Hydrochloride) Are Indicated For The Treatment Of Major Depressive Disorder (mdd). Efficacy Of Venlafaxine In Mdd Was Shown In Both Short-Term Trials And A Longer-Term Trial In Mdd [see Clinical Studies (14.1) ]. A Major Depressive Episode (dsm-Iv) Implies A Prominent And Relatively Persistent (nearly Every Day For At Least 2 Weeks) Depressed Mood Or The Loss Of Interest Or Pleasure In Nearly All Activities, Representing A Change From Previous Functioning, And Includes The Presence Of At Least Five Of The Following Nine Symptoms During The Same Two-Week Period: Depressed Mood, Markedly Diminished Interest Or Pleasure In Usual Activities, Significant Change In Weight And/or Appetite, Insomnia Or Hypersomnia, Psychomotor Agitation Or Retardation, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, A Suicide Attempt Or Suicidal Ideation. 1.2 Social Anxiety Disorder Venlafaxine Extended Release Tablets Are Indicated For The Treatment Of Social Anxiety Disorder (sad), Also Known As Social Phobia, As Defined In Dsm-Iv. Social Anxiety Disorder (dsm-Iv) Is Characterized By A Marked And Persistent Fear Of 1 Or More Social Or Performance Situations In Which The Person Is Exposed To Unfamiliar People Or To Possible Scrutiny By Others. Exposure To The Feared Situation Almost Invariably Provokes Anxiety, Which May Approach The Intensity Of A Panic Attack. The Feared Situations Are Avoided Or Endured With Intense Anxiety Or Distress. The Avoidance, Anxious Anticipation, Or Distress In The Feared Situation(s) Interferes Significantly With The Person's Normal Routine, Occupational Or Academic Functioning, Or Social Activities Or Relationships, Or There Is A Marked Distress About Having The Phobias. Lesser Degrees Of Performance Anxiety Or Shyness Generally Do Not Require Psychopharmacological Treatment. Efficacy Of Venlafaxine Extended Release In The Treatment Of Sad Was Established In Short-Term Sad Trials [see Clinical Studies (14.2) ].

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Povidones POVIDONES Unresolved
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
5. 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.
6. Cellulose Acetate CELLULOSE ACETATE Unresolved
7. Hypromelloses HYPROMELLOSES Unresolved
8. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
11. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

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

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