Brexpiprazole
ANDA 213587, held by Prinston Pharma Inc. Brexpiprazole.
- First approved: Not approved
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2024 | Original application | Tentative approval |
Products
6 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Brexpiprazole0.25MG · tablet;oral | Brexpiprazole | None (tentative approval) |
| Brexpiprazole0.5MG · tablet;oral | Brexpiprazole | None (tentative approval) |
| Brexpiprazole1MG · tablet;oral | Brexpiprazole | None (tentative approval) |
| Brexpiprazole2MG · tablet;oral | Brexpiprazole | None (tentative approval) |
| Brexpiprazole3MG · tablet;oral | Brexpiprazole | None (tentative approval) |
| Brexpiprazole4MG · tablet;oral | Brexpiprazole | None (tentative approval) |
Identifiers
- Application
- ANDA 213587
- Drugs@FDA
- Overview at FDA
- Company
- Prinston Pharmaceutical
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