Application Nr Approved Date Route Status External Links
ANDA078858 2009-01-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levetiracetam Is Indicated For Adjunctive Therapy In The Treatment Of: Partial Onset Seizures In Patients One Month Of Age And Older With Epilepsy (1.1) Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy (1.2) Primary Generalized Tonic-Clonic Seizures In Patients 6 Years Of Age And Older With Idiopathic Generalized Epilepsy (1.3) 1.1 Partial Onset Seizures Levetiracetam Tablets, Usp Are Indicated As Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Adults And Children 1 Month Of Age And Older With Epilepsy. 1.2 Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy Levetiracetam Tablets, Usp Are Indicated As Adjunctive Therapy In The Treatment Of Myoclonic Seizures In Adults And Adolescents 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam Tablets, Usp Are Indicated As Adjunctive Therapy In The Treatment Of Primary Generalized Tonic-Clonic Seizures In Adults And Children 6 Years Of Age And Older With Idiopathic Generalized Epilepsy.

All Formulated Excipients (8 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. Starch, Corn STARCH, CORN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
6. Povidones POVIDONES Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levetiracetam LEVETIRACETAM ZINC1547851

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