ANDA 200152, held by Teva Pharms USA Inc. Armodafinil.
As of Nov 14, 2026, ANDA 200152 (Armodafinil), held by Teva Pharms USA Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2014 | Original application | Tentative approval | None posted |
| Armodafinil50MG · tablet;oral | Armodafinil | None (tentative approval) |
| Armodafinil100MG · tablet;oral | Armodafinil | None (tentative approval) |
| Armodafinil150MG · tablet;oral | Armodafinil | None (tentative approval) |
| Armodafinil200MG · tablet;oral | Armodafinil | None (tentative approval) |
| Armodafinil250MG · tablet;oral | Armodafinil | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters