# LYBALVI
> **NDA213378** · New Drug Application · Sponsor: ALKERMES INC · Approved 2021-05-28
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213378)
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