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

Indications And Usage Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Capsules Usp Are Indicated For The Treatment Of Major Depressive Disorder. The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules Usp In The Treatment Of Major Depressive Disorder Was Established In 8 And 12 Week Controlled Trials Of Adult Outpatients Whose Diagnoses Corresponded Most Closely To The Dsm-Iii-R Or Dsm-Iv Category Of Major Depressive Disorder (see Clinical Trials). 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. The Efficacy Of Venlafaxine Hydrochloride Tablets Usp (immediate Release) In The Treatment Of Major Depressive Disorder In Adult Inpatients Meeting Diagnostic Criteria For Major Depressive Disorder With Melancholia Was Established In A 4 Week Controlled Trial (see Clinical Trials). The Safety And Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules Usp In Hospitalized Depressed Patients Have Not Been Adequately Studied. The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules Usp In Maintaining A Response In Major Depressive Disorder For Up To 26 Weeks Following 8 Weeks Of Acute Treatment Was Demonstrated In A Placebo-Controlled Trial. The Efficacy Of Venlafaxine Hydrochloride Tablets Usp (immediate Release) In Maintaining A Response In Patients With Recurrent Major Depressive Disorder 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 Hydrochloride Tablets Usp/venlafaxine Hydrochloride Extended-Release Capsules Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration). Panic Disorder Venlafaxine Hydrochloride Extended-Release Capsules Usp Are Indicated For The Treatment Of Panic Disorder, With Or Without Agoraphobia, As Defined In Dsm-Iv. Panic Disorder Is Characterized By The Occurrence Of Unexpected Panic Attacks And Associated Concern About Having Additional Attacks, Worry About The Implications Or Consequences Of The Attacks, And/or A Significant Change In Behavior Related To The Attacks. Panic Disorder (dsm-Iv) Is Characterized By Recurrent, Unexpected Panic Attacks, I.e., A Discrete Period Of Intense Fear Or Discomfort, In Which Four (or More) Of The Following Symptoms Develop Abruptly And Reach A Peak Within 10 Minutes: 1) Palpitations, Pounding Heart, Or Accelerated Heart Rate; 2) Sweating; 3) Trembling Or Shaking; 4) Sensations Of Shortness Of Breath Or Smothering; 5) Feeling Of Choking; 6) Chest Pain Or Discomfort; 7) Nausea Or Abdominal Distress; 8) Feeling Dizzy, Unsteady, Lightheaded, Or Faint; 9) Derealization (feelings Of Unreality) Or Depersonalization (being Detached From Oneself); 10) Fear Of Losing Control; 11) Fear Of Dying; 12) Paresthesias (numbness Or Tingling Sensations); 13) Chills Or Hot Flushes. The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules Usp In The Treatment Of Panic Disorder Was Established In Two 12 Week Placebo-Controlled Trials In Adult Outpatients With Panic Disorder (dsm-Iv). The Efficacy Of Venlafaxine Hydrochloride Extended-Release Capsules Usp In Prolonging Time To Relapse In Panic Disorder Among Responders Following 12 Weeks Of Open-Label Acute Treatment Was Demonstrated In A Placebo-Controlled Study (see Clinical Pharmacology, Clinical Trials). Nevertheless, The Physician Who Elects To Use Venlafaxine Hydrochloride Extended-Release Capsules Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration).

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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