# SUVOREXANT
> **ANDA219386** · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD UNIT III · Approved 2025-12-22
## Drug
- **FDA Application Number:** ANDA219386
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SUVOREXANT
- **Generic name:** Suvorexant
- **Active ingredients:** SUVOREXANT
- **Dosage form:** TABLET
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** HETERO LABS LTD UNIT III
- **First approval:** 2025-12-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219386)
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