Application Nr Approved Date Route Status External Links
ANDA078790 2008-07-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Mania Divalproex Sodium Delayed-Release Tablets Are Indicated For The Treatment Of The Manic Episodes Associated With Bipolar Disorder. 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 Judgement, Aggressiveness, And Possible Hostility. The Efficacy Of Divalproex Sodium Delayed-Release Tablets Was Established In 3-Week Trials With Patients Meeting Dsmiii-R Criteria For Bipolar Disorder Who Were Hospitalized For Acute Mania (see Clinical Trials Under Clinical Pharmacology). The Safety And Effectiveness Of Divalproex Sodium Delayed-Release Tablets For Long-Term Use In Mania, I.e., More Than 3 Weeks, Has Not Been Systematically Evaluated In Controlled Clinical Trials. Therefore, Healthcare Providers Who Elect To Use Divalproex Sodium Delayed-Release Tablets For Extended Periods Should Continually Reevaluate The Long-Term Usefulness Of The Drug For The Individual Patient. Epilepsy Divalproex Sodium Extended-Release Tablets Are Indicated As Monotherapy And Adjunctive Therapy In The Treatment Of Patients With Complex Partial Seizures That Occur Either In Isolation Or In Association With Other Types Of Seizures. Divalproex Sodium Delayed-Release Tablets Are Also Indicated For Use As Sole And Adjunctive Therapy In The Treatment Of Simple And Complex Absence Seizures And Adjunctively In Patients 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. Migraine Divalproex Sodium Delayed-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 Valproic Acid 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: Usage In Pregnancy, Precautions: Information For Patients). See Warnings For Statement Regarding Fatal Hepatic Dysfunction.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved

Active Ingredients ( 1 Total)

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

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