# LUMATEPERONE
> **ANDA219229** · Abbreviated New Drug Application (Generic) · Sponsor: DR. REDDY'S LABORATORIES LIMITED · Approved 2025-08-06
## Drug
- **FDA Application Number:** ANDA219229
- **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:** DR. REDDY'S LABORATORIES LIMITED
- **First approval:** 2025-08-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219229)
---
*AI Analytics · CC0 1.0*