Application Nr Approved Date Route Status External Links
ANDA079163 2011-04-05 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Divalproex Sodium Delayed Release Tablets Are An Anti-Epileptic Drug Indicated For: Treatment Of Manic Episodes Associated With Bipolar Disorder ( ) 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 Delayed Release Tablets Are A Valproate And 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 Judgment, Aggressiveness, And Possible Hostility. The Efficacy Of Divalproex Sodium Delayed Release Tablets Were Established In 3-Week Trials With Patients Meeting Dsm-Iii-R Criteria For Bipolar Disorder Who Were Hospitalized For Acute Mania . [see Clinical Studies ( )] 14.1 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 Demonstrated 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. 1.2 Epilepsy Divalproex Sodium Delayed 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. 1.3 Migraine Divalproex Sodium Delayed Release Tablets Are Indicated For Prophylaxis Of Migraine Headaches. There Is No Evidence That Divalproex Sodium Delayed Release Tablets Are Useful In The Acute Treatment Of Migraine Headaches. 1.4 Important Limitations Because Of The Risk To The Fetus Of Decreased Iq, Neural Tube Defects, And Other Major Congenital Malformations, Which May Occur Very Early In Pregnancy, Valproate Should Not Be Administered To A Woman Of Childbearing Potential Unless The Drug Is Essential To The Management Of Her Medical Condition [see Warnings And Precautions ( , , ), Use In Specific Populations ( ), And Patient Counseling Information ( )]. 5.2 5.3 5.4 8.1 17 Divalproex Sodium Delayed Release Tablets Are Contraindicated For Prophylaxis Of Migraine Headaches In Women Who Are Pregnant.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Povidones POVIDONES Unresolved
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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