← FDA Drug Approvals (Drugs@FDA)
LYBALVI
NDA · New Drug Application · Sponsor: ALKERMES INC · Approved 2021-05-28
Drug application
- FDA Application #
NDA213378- Application type
- New Drug Application
- Brand name
- LYBALVI
- Generic name
- OLANZAPINE AND SAMIDORPHAN L-MALATE
- Active ingredients
- OLANZAPINE; SAMIDORPHAN L-MALATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKERMES INC
- Manufacturer
- Alkermes, Inc.
- First approval
- 2021-05-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown