NDA 205004, held by Fresenius Kabi USA. Bortezomib.
As of Nov 14, 2026, NDA 205004 (Bortezomib), held by Fresenius Kabi USA, was first approved by FDA on Nov 6, 2017, with 2 approved supplements and 0 published complete response letters.
| Sep 20, 2021 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Nov 6, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bortezomib3.5MG/VIAL · powder;intravenous | Bortezomib | Discontinued |
| Sep 20, 2021 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jul 12, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Nov 6, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
