Brexpiprazole
ANDA 213731, held by Apotex. Brexpiprazole.
- First approved: Feb 24, 2025
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2025 | Original application | Approved |
Products
5 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Brexpiprazole0.25MG · tablet;oral | Brexpiprazole | Discontinued |
| Brexpiprazole0.5MG · tablet;oral | Brexpiprazole | Discontinued |
| Brexpiprazole1MG · tablet;oral | Brexpiprazole | Discontinued |
| Brexpiprazole2MG · tablet;oral | Brexpiprazole | Discontinued |
| Brexpiprazole3MG · tablet;oral | Brexpiprazole | Discontinued |
Identifiers
- Application
- ANDA 213731
- Drugs@FDA
- Overview at FDA
- Company
- Apotex
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters