Application Nr Approved Date Route Status External Links
ANDA077206 2007-02-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Major Depressive Disorder Sertraline Hydrochloride Tablets Usp Are Indicated For The Treatment Of Major Depressive Disorder In Adults. The Efficacy Of Sertraline Hydrochloride Tablets Usp In The Treatment Of A Major Depressive Episode Was Established In Six To Eight Week Controlled Trials Of Adult Outpatients Whose Diagnoses Corresponded Most Closely To The Dsm-Iii Category Of Major Depressive Disorder (see Clinical Trials Under Clinical Pharmacology ). 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 Antidepressant Action Of Sertraline Hydrochloride Tablets Usp In Hospitalized Depressed Patients Has Not Been Adequately Studied. The Efficacy Of Sertraline Hydrochloride Tablets Usp In Maintaining An Antidepressant Response For Up To 44 Weeks Following 8 Weeks Of Open-Label Acute Treatment (52 Weeks Total) Was Demonstrated In A Placebo-Controlled Trial. The Usefulness Of The Drug In Patients Receiving Sertraline Hydrochloride Tablets Usp For Extended Periods Should Be Reevaluated Periodically (see Clinical Trials Under Clinical Pharmacology ). Obsessive-Compulsive Disorder Sertraline Hydrochloride Tablets Usp Are Indicated For The Treatment Of Obsessions And Compulsions In Patients With Obsessive-Compulsive Disorder (ocd), As Defined In The Dsm-Iii-R; I.e., The Obsessions Or Compulsions Cause Marked Distress, Are Time-Consuming, Or Significantly Interfere With Social Or Occupational Functioning. The Efficacy Of Sertraline Hydrochloride Tablets Usp Was Established In 12-Week Trials With Obsessive-Compulsive Outpatients Having Diagnoses Of Obsessive-Compulsive Disorder As Defined According To Dsm-Iii Or Dsm-Iii-R Criteria (see Clinical Trials Under Clinical Pharmacology ). Obsessive-Compulsive Disorder Is Characterized By Recurrent And Persistent Ideas, Thoughts, Impulses, Or Images (obsessions) That Are Ego-Dystonic And/or Repetitive, Purposeful, And Intentional Behaviors (compulsions) That Are Recognized By The Person As Excessive Or Unreasonable. The Efficacy Of Sertraline Hydrochloride Tablets Usp In Maintaining A Response, In Patients With Ocd Who Responded During A 52-Week Treatment Phase While Taking Sertraline Hydrochloride Tablets Usp And Were Then Observed For Relapse During A Period Of Up To 28 Weeks, Was Demonstrated In A Placebo-Controlled Trial (see Clinical Trials Under Clinical Pharmacology ). Nevertheless, The Physician Who Elects To Use Sertraline Hydrochloride Tablets 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 Sertraline Hydrochloride Tablets Usp Are Indicated For The Treatment Of Panic Disorder In Adults, 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. The Efficacy Of Sertraline Hydrochloride Tablets Usp Were Established In Three 10 To 12 Week Trials In Adult Panic Disorder Patients Whose Diagnoses Corresponded To The Dsm-Iii-R Category Of Panic Disorder (see Clinical Trials Under Clinical Pharmacology ). 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 Sertraline Hydrochloride Tablets Usp In Maintaining A Response, In Adult Patients With Panic Disorder Who Responded During A 52-Week Treatment Phase While Taking Sertraline Hydrochloride Tablets Usp And Were Then Observed For Relapse During A Period Of Up To 28 Weeks, Was Demonstrated In A Placebo-Controlled Trial (see Clinical Trials Under Clinical Pharmacology ). Nevertheless, The Physician Who Elects To Use Sertraline Hydrochloride Tablets Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration ). Posttraumatic Stress Disorder (ptsd) Sertraline Hydrochloride Tablets Usp Areindicated For The Treatment Of Posttraumatic Stress Disorder In Adults. The Efficacy Of Sertraline Hydrochloride Tablets Usp In The Treatment Of Ptsd Was Established In Two 12-Week Placebo-Controlled Trials Of Adult Outpatients Whose Diagnosis Met Criteria For The Dsm-Iii-R Category Of Ptsd (see Clinical Trials Under Clinical Pharmacology ). Ptsd, As Defined By Dsm-Iii-R/iv, Requires Exposure To A Traumatic Event That Involved Actual Or Threatened Death Or Serious Injury, Or Threat To The Physical Integrity Of Self Or Others, And A Response Which Involves Intense Fear, Helplessness, Or Horror. Symptoms That Occur As A Result Of Exposure To The Traumatic Event Include Reexperiencing Of The Event In The Form Of Intrusive Thoughts, Flashbacks Or Dreams, And Intense Psychological Distress And Physiological Reactivity On Exposure To Cues To The Event; Avoidance Of Situations Reminiscent Of The Traumatic Event, Inability To Recall Details Of The Event, And/or Numbing Of General Responsiveness Manifested As Diminished Interest In Significant Activities, Estrangement From Others, Restricted Range Of Affect, Or Sense Of Foreshortened Future; And Symptoms Of Autonomic Arousal Including Hypervigilance, Exaggerated Startle Response, Sleep Disturbance, Impaired Concentration, And Irritability Or Outbursts Of Anger. A Ptsd Diagnosis Requires That The Symptoms Are Present For At Least A Month And That They Cause Clinically Significant Distress Or Impairment In Social, Occupational, Or Other Important Areas Of Functioning. The Efficacy Of Sertraline Hydrochloride Tablets Usp In Maintaining A Response In Adult Patients With Ptsd For Up To 28 Weeks Following 24 Weeks Of Open-Label Treatment Was Demonstrated In A Placebo-Controlled Trial. Nevertheless, The Physician Who Elects To Use Sertraline Hydrochloride Tablets Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration ). Premenstrual Dysphoric Disorder (pmdd) Sertraline Hydrochloride Tablets Usp Are Indicated For The Treatment Of Premenstrual Dysphoric Disorder (pmdd) In Adults. The Efficacy Of Sertraline Hydrochloride Tablets Usp In The Treatment Of Pmdd Was Established In 2 Placebo-Controlled Trials Of Female Adult Outpatients Treated For 3 Menstrual Cycles Who Met Criteria For The Dsm-Iii­-R/iv Category Of Pmdd (see Clinical Trials Under Clinical Pharmacology ). The Essential Features Of Pmdd Include Markedly Depressed Mood, Anxiety Or Tension, Affective Lability, And Persistent Anger Or Irritability. Other Features Include Decreased Interest In Activities, Difficulty Concentrating, Lack Of Energy, Change In Appetite Or Sleep, And Feeling Out Of Control. Physical Symptoms Associated With Pmdd Include Breast Tenderness, Headache, Joint And Muscle Pain, Bloating And Weight Gain. These Symptoms Occur Regularly During The Luteal Phase And Remit Within A Few Days Following Onset Of Menses; The Disturbance Markedly Interferes With Work Or School Or With Usual Social Activities And Relationships With Others. In Making The Diagnosis, Care Should Be Taken To Rule Out Other Cyclical Mood Disorders That May Be Exacerbated By Treatment With An Antidepressant. The Effectiveness Of Sertraline Hydrochloride Tablets Usp In Long-Term Use, That Is, For More Than 3 Menstrual Cycles, Has Not Been Systematically Evaluated In Controlled Trials. Therefore, The Physician Who Elects To Use Sertraline Hydrochloride Tablets Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration ). Social Anxiety Disorder Sertraline Hydrochloride Tablets Usp Are Indicated For The Treatment Of Social Anxiety Disorder, Also Known As Social Phobia In Adults. The Efficacy Of Sertraline Hydrochloride Tablets Usp In The Treatment Of Social Anxiety Disorder Was Established In Two Placebo-Controlled Trials Of Adult Outpatients With A Diagnosis Of Social Anxiety Disorder As Defined By Dsm-Iv Criteria (see Clinical Trials Under Clinical Pharmacology ). Social Anxiety Disorder, As Defined By Dsm-Iv, Is Characterized By Marked And Persistent Fear Of Social Or Performance Situations Involving Exposure To Unfamiliar People Or Possible Scrutiny By Others And By Fears Of Acting In A Humiliating Or Embarrassing Way. Exposure To The Feared Social Situation Almost Always Provokes Anxiety And Feared Social Or Performance Situations Are Avoided Or Else Are Endured With Intense Anxiety Or Distress. In Addition, Patients Recognize That The Fear Is Excessive Or Unreasonable And The Avoidance And Anticipatory Anxiety Of The Feared Situation Is Associated With Functional Impairment Or Marked Distress. The Efficacy Of Sertraline Hydrochloride Tablets Usp In Maintaining A Response In Adult Patients With Social Anxiety Disorder For Up To 24 Weeks Following 20 Weeks Of Sertraline Hydrochloride Tablets Usp Treatment Was Demonstrated In A Placebo-Controlled Trial. Physicians Who Prescribe Sertraline Hydrochloride Tablets Usp For Extended Periods Should Periodically Re-­evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Clinical Trials Under Clinical Pharmacology ).

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Calcium Phosphate, Dibasic, Dihydrate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE Molecular
3. 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.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE ZINC1853550

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