Application Nr Approved Date Route Status External Links
ANDA077296 2008-07-31 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 Tablet Is 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 Tablet Was Established In 3-Week Trials With Patients Meeting Dsm-Iii-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 Delayed-Release Tablet Is 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 Tablet Is 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 Tablet Is 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. Because Valproic Acid May Be A Hazard To The Fetus, Divalproex Sodium Delayed-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 (13 Total)

Name Structure Kind Function Status
1. Povidones POVIDONES Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Hypromelloses HYPROMELLOSES Unresolved
6. Simethicone Emulsion SIMETHICONE EMULSION Unresolved
7. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
8. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
11. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
13. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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