Brexpiprazole
ANDA 213788, held by Accord Hlthcare 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 |
|---|---|---|---|
| Aug 17, 2021 | Original application | Tentative approval |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Brexpiprazole0.25MG · tablet; oral | Brexpiprazole | None (tentative approval) |
Identifiers
- Application
- ANDA 213788
- Drugs@FDA
- Overview at FDA
- Company
- Accord Healthcare
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