Application Nr Approved Date Route Status External Links
ANDA077960 2006-10-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Valproic Acid Oral Solution Is An Antiepileptic Drug Indicated For: Monotherapy And Adjunctive Therapy Of Complex Partial Seizures; Sole And Adjunctive Therapy Of Simple And Complex Absence Seizures; Adjunctive Therapy In Patients With Multiple Seizure Types That Include Absence Seizures (1) 1.1 Epilepsy Valproic Acid Oral Solution 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. Valproic Acid Oral Solution Is 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 Which 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. See Warnings And Precautions (5.1) For Statement Regarding Fatal Hepatic Dysfunction. 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 (5 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
3. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
4. Water WATER Molecular
5. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Valproic Acid VALPROIC ACID ZINC4501392

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