# LUMATEPERONE
> **ANDA219200** · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2025-05-27
## Drug
- **FDA Application Number:** ANDA219200
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LUMATEPERONE
- **Generic name:** Lumateperone
- **Active ingredients:** LUMATEPERONE
- **Dosage form:** CAPSULE
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ALKEM LABS LTD
- **First approval:** 2025-05-27
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219200)
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