Application Nr Approved Date Route Status External Links
ANDA078705 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: 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) 1.2 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 (9 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Glyceryl Dibehenate GLYCERYL DIBEHENATE Unresolved
5. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Lecithin LECITHIN Unresolved

Active Ingredients ( 1 Total)

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

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