Application Nr Approved Date Route Status External Links
ANDA078919 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Divalproex Sodium Delayed-Release Capsules (sprinkle) Are Anti-Epileptic Drug 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 ) 1.1 Epilepsy Divalproex Sodium Delayed-Release Capsules (sprinkle) 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 Delayed-Release Capsules (sprinkle) 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. 1.2 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 ( 5.2 , 5.3 , 5.4 ), Use In Specific Populations ( 8.1 ), And Patient Counseling Information (17) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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