← FDA Drug Approvals (Drugs@FDA)
ELEPSIA XR
NDA · New Drug Application · Sponsor: TRIPOINT · Approved 2018-12-20
Drug application
- FDA Application #
NDA204417
- Application type
- New Drug Application
- Brand name
- ELEPSIA XR
- Generic name
- LEVETIRACETAM
- Active ingredients
- LEVETIRACETAM
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- TRIPOINT
- Manufacturer
- TRIPOINT THERAPEUTICS, LLC
- First approval
- 2018-12-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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