NDA 220712, held by Amneal Pharms Ny. Carfilzomib.
As of Nov 13, 2026, NDA 220712 (Kitprozy), held by Amneal Pharms Ny, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 2026 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kitprozy60MG/ML, 2/ML · vial; single-use | Carfilzomib | Rx |
| Kitprozy120MG/2ML (60MG/ML), 2ML · vial; single-use | Carfilzomib | Rx |
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