Brexpiprazole
ANDA 213683, held by Alembic. Brexpiprazole.
- First approved: Jan 13, 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 |
|---|---|---|---|
| Jan 13, 2025 | Original application | Approved | None posted |
Products
6 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Brexpiprazole0.25MG · tablet;oral | Brexpiprazole | Rx |
| Brexpiprazole0.5MG · tablet;oral | Brexpiprazole | Rx |
| Brexpiprazole1MG · tablet;oral | Brexpiprazole | Rx |
| Brexpiprazole2MG · tablet;oral | Brexpiprazole | Rx |
| Brexpiprazole3MG · tablet;oral | Brexpiprazole | Rx |
| Brexpiprazole4MG · tablet;oral | Brexpiprazole | Rx |
Identifiers
- Application
- ANDA 213683
- Drugs@FDA
- Overview at FDA
- Company
- Alembic, LLC
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