Application Nr Approved Date Route Status External Links
ANDA076919 2008-11-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levetiracetam Is An Antiepileptic Drug Indicated For Adjunctive Therapy In The Treatment Of: Partial Onset Seizures In Patients 4 Years 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 Are Indicated As Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Adults And Children 4 Years Of Age And Older With Epilepsy. Information Describing The Use Of Levetiracetam In Pediatric Patients Less Than 4 Years Of Age As Adjunctive Therapy In The Treatment Of Partial Onset Seizures Is Approved For Ucb, Inc.’s Levetiracetam Tablets And Oral Solution. However, Due To Ucb, Inc.’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. 1.2 Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy Levetiracetam Tablets 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 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 (9 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. Croscarmellose Sodium CROSCARMELLOSE SODIUM 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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Povidones POVIDONES Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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