Application Nr Approved Date Route Status External Links
NDA204417 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Elepsia Xr Is Indicated As Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Patients ≥12 Years Of Age With Epilepsy. Elepsia Xr Is Indicated For Adjunctive Therapy In The Treatment Of Partial Onset Seizures In Patients ≥12 Years Of Age With Epilepsy(1)

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Povidones POVIDONES Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate Copolymer DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER Unresolved
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer 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. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
7. 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.
8. Ethylcelluloses ETHYLCELLULOSES Unresolved
9. Dibutyl Sebacate DIBUTYL SEBACATE Molecular
10. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
11. Polysorbate 20 POLYSORBATE 20 Unresolved
12. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
13. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

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

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