NDA 208645, held by Actavis LLC. Bortezomib.
As of Nov 13, 2026, NDA 208645 (Bortezomib), held by Actavis LLC, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2016 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Bortezomib2.5MG/ML · injectable; injection | Bortezomib | None (tentative approval) |
| Bortezomib3.5MG/1.4ML · injectable; injection | Bortezomib | 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