← FDA Drug Approvals (Drugs@FDA)
EXXUA
NDA · New Drug Application · Sponsor: FABRE KRAMER · Approved 2023-09-22
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown