Application Nr Approved Date Route Status External Links
ANDA076921 2004-10-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Mirtazapine Tablets, Usp Are Indicated For The Treatment Of Major Depressive Disorder. The Efficacy Of Mirtazapine In The Treatment Of Major Depressive Disorder Was Established In 6-Week Controlled Trials Of Outpatients Whose Diagnoses Corresponded Most Closely To The Diagnostic And Statistical Manual Of Mental Disorders-3rd Edition (dsm-Iii) Category Of Major Depressive Disorder (see Clinical Pharmacology). A Major Depressive Episode (dsm-Iv) Implies A Prominent And Relatively Persistent (nearly Every Day For At Least 2 Weeks) Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning, And Includes At Least 5 Of The Following 9 Symptoms: Depressed Mood, Loss Of Interest 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 Effectiveness Of Mirtazapine In Hospitalized Depressed Patients Has Not Been Adequately Studied. The Efficacy Of Mirtazapine In Maintaining A Response In Patients With Major Depressive Disorder For Up To 40 Weeks Following 8 To 12 Weeks Of Initial Open-Label Treatment Was Demonstrated In A Placebo-Controlled Trial. Nevertheless, The Physician Who Elects To Use Mirtazapine For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Clinical Pharmacology).

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. 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.
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Hypromelloses HYPROMELLOSES Unresolved
5. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Mirtazapine MIRTAZAPINE ZINC509

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