Application Nr Approved Date Route Status External Links
ANDA078932 2010-12-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Venlafaxine Tablets Are Indicated For The Treatment Of Major Depressive Disorder. The Efficacy Of Venlafaxine Tablets In The Treatment Of Major Depressive Disorder Was Established In 6-Week Controlled Trials Of Adult Outpatients Whose Diagnoses Corresponded Most Closely To The Dsm-Iii Or Dsm-Iii-R Category Of Major Depression And In A 4-Week Controlled Trial Of Inpatients Meeting Diagnostic Criteria For Major Depression With Melancholia (see Clinical Trials ). A Major Depressive Episode Implies A Prominent And Relatively Persistent Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning (nearly Every Day For At Least 2 Weeks); It Should Include At Least 4 Of The Following 8 Symptoms: Change In Appetite, Change In Sleep, Psychomotor Agitation Or Retardation, Loss Of Interest In Usual Activities Or Decrease In Sexual Drive, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, And A Suicide Attempt Or Suicidal Ideation. The Efficacy Of Venlafaxine Hydrochloride Extended Release Capsules In Maintaining An Antidepressant Response For Up To 26 Weeks Following 8 Weeks Of Acute Treatment Was Demonstrated In A Placebo-Controlled Trial. The Efficacy Of Venlafaxine Tablets In Maintaining An Antidepressant Response In Patients With Recurrent Depression Who Had Responded And Continued To Be Improved During An Initial 26 Weeks Of Treatment And Were Then Followed For A Period Of Up To 52 Weeks Was Demonstrated In A Second Placebo-Controlled Trial (see Clinical Trials ). Nevertheless, The Physician Who Elects To Use Venlafaxine Tablets/ Venlafaxine Hydrochloride Extended Release Capsules For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Ferric Oxide Red FERRIC OXIDE RED Molecular
2. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular

Active Ingredients ( 1 Total)

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

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