Levetiracetam

Product manufactured by Direct Rx

Application Nr Approved Date Route Status External Links
ANDA078154 2009-01-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Section 1.1 Partial Onset Seizures Levetiracetam Tablets Usp 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. 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 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 (10 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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Povidones POVIDONES Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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