Application Nr Approved Date Route Status External Links
ANDA078445 2009-08-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Divalproex Sodium Extended-Release Tablets Are Indicated For: Acute Treatment Of Manic Or Mixed Episodes Associated With Bipolar Disorder, With Or Without Psychotic Features. (1.1) Monotherapy And Adjunctive Therapy Of Complex Partial Seizures And Simple And Complex Absence Seizures; Adjunctive Therapy In Patients With Multiple Seizure Types That Include Absence Seizures (1.2) Prophylaxis Of Migraine Headaches (1.3) 1.1 Mania Divalproex Sodium Extended-Release Tablets Are Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar Disorder, With Or Without Psychotic Features. A Manic Episode Is A Distinct Period Of Abnormally And Persistently Elevated, Expansive, Or Irritable Mood. Typical Symptoms Of Mania Include Pressure Of Speech, Motor Hyperactivity, Reduced Need For Sleep, Flight Of Ideas, Grandiosity, Poor Judgment, Aggressiveness, And Possible Hostility. A Mixed Episode Is Characterized By The Criteria For A Manic Episode In Conjunction With Those For A Major Depressive Episode (depressed Mood, Loss Of Interest Or Pleasure In Nearly All Activities). The Efficacy Of Divalproex Sodium Extended-Release Tablets Is Based In Part On Studies Of Divalproex Sodium Delayed Release Tablets In This Indication, And Was Confirmed In A 3-Week Trial With Patients Meeting Dsm-Iv Tr Criteria For Bipolar I Disorder, Manic Or Mixed Type, Who Were Hospitalized For Acute Mania [see Clinical Studies (14.1)]. The Safety And Effectiveness Of Valproate For Long-Term Use In Mania, I.e., More Than 3 Weeks, Has Not Been Systematically Evaluated In Controlled Clinical Trials. Therefore, Physicians Who Elect To Use Divalproex Sodium Extended-Release Tablets For Extended Periods Should Continually Reevaluate The Long-Term Risk-Benefits Of The Drug For The Individual Patient. 1.2 Epilepsy Divalproex Sodium Extended-Release Tablets Are Indicated As Monotherapy And Adjunctive Therapy In The Treatment Of Adult Patients And Pediatric Patients Down To The Age Of 10 Years With Complex Partial Seizures That Occur Either In Isolation Or In Association With Other Types Of Seizures. Divalproex Sodium Extended-Release Tablets Are Also Indicated For Use As Sole And Adjunctive Therapy In The Treatment Of Simple And Complex Absence Seizures In Adults And Children 10 Years Of Age Or Older, And Adjunctively In Adults And Children 10 Years Of Age Or Older With Multiple Seizure Types That Include Absence Seizures. Simple Absence Is Defined As Very Brief Clouding Of The Sensorium Or Loss Of Consciousness Accompanied By Certain Generalized Epileptic Discharges Without Other Detectable Clinical Signs. Complex Absence Is The Term Used When Other Signs Are Also Present. 1.3 Migraine Divalproex Sodium Extended-Release Tablets Are Indicated For Prophylaxis Of Migraine Headaches. There Is No Evidence That Divalproex Sodium Extended-Release Tablets Are Useful In The Acute Treatment Of Migraine Headaches. Because It May Be A Hazard To The Fetus, Divalproex Sodium Extended-Release Tablets Should Be Considered For Women Of Childbearing Potential Only After This Risk Has Been Thoroughly Discussed With The Patient And Weighed Against The Potential Benefits Of Treatment [see Warnings And Precautions (5.2), Patient Counseling Information (17.3)].

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Hydroxyethyl Cellulose HYDROXYETHYL CELLULOSE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
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. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Povidones POVIDONES Unresolved
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Divalproex Sodium DIVALPROEX SODIUM ZINC3008621

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