Application Nr Approved Date Route Status External Links
ANDA090906 2016-10-31 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Levetiracetam Is Indicated As Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Adults And Children 4 Years Of Age And Older With Epilepsy. Levetiracetam Is Indicated As Adjunctive Therapy In The Treatment Of Myoclonic Seizures In Adults And Adolescents 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy. Levetiracetam Is Indicated As Adjunctive Therapy In The Treatment Of Primary Generalized Tonicoclonic 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. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. 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.
7. Povidones POVIDONES Unresolved
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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