Application Nr Approved Date Route Status External Links
ANDA202167 2015-09-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levetiracetam Extended-Release Tablets Usp Are Indicated As Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Patients 12 Years Of Age And Older With Epilepsy. Levetiracetam Extended-Release Tablets Usp Are Indicated For Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Patients 12 Years Of Age And Older With Epilepsy (1)

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
2. Compressible Sugar COMPRESSIBLE SUGAR Molecular
3. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. 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.
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Kaolin KAOLIN Molecular
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.
10. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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