# EXXUA
> **NDA021164** · New Drug Application · Sponsor: FABRE KRAMER · Approved 2023-09-22
## Drug
- **FDA Application Number:** NDA021164
- **Application type:** New Drug Application
- **Brand name:** EXXUA
- **Generic name:** GEPIRONE
- **Active ingredients:** GEPIRONE HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** FABRE KRAMER
- **Manufacturer:** Aytu Therapeutics, LLC
- **First approval:** 2023-09-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021164)
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