Application Nr Approved Date Route Status External Links
ANDA077032 2004-11-12 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Citalopram Hbr, Usp Is Indicated For The Treatment Of Depression. The Efficacy Of Citalopram Tablets, Usp In The Treatment Of Depression Was Established In 4-6 Week, Controlled Trials Of Outpatients Whose Diagnosis Corresponded Most Closely To The Dsm-Lll And Dsm-Lll-R 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 Five Of The Following Nine 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 Antidepressant Action Of Citalopram Tablets, Usp In Hospitalized Depressed Patients Has Not Been Adequately Studied. The Efficacy Of Citalopram Tablets, Usp In Maintaining An Antidepressant Response For Up To 24 Weeks Following 6 To 8 Weeks Of Acute Treatment Was Demonstrated In Two Placebo-Controlled Trials (see Clinical Pharmacology ). Nevertheless, The Physician Who Elects To Use Citalopram Tablets, Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Citalopram Hydrobromide CITALOPRAM HYDROBROMIDE ZINC3794601

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