NDA 212782, held by Shilpa. Bortezomib.
As of Nov 14, 2026, NDA 212782 (Bortezomib), held by Shilpa, was first approved by FDA on Aug 26, 2024, with 0 approved supplements and 2 published complete response letters.
Bortezomib Injection is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma treatment of adult patients with mantle cell lymphoma 1.1 Multiple Myeloma Bortezomib Injection is indicated for the treatment of adult patients with multiple myeloma. 1.2 Mantle Cell Lymphoma Bortezomib Injection is indicated for the treatment of adult patients with mantle cell lymphoma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Aug 1, 2023 | BortezomibProduct Quality, Facility Inspections | Approved |
| Mar 10, 2020 | BortezomibClinical, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bortezomib3.5MG/1.4ML (2.5MG/ML) · solution;intravenous, subcutaneous | Bortezomib | RxReference drug |
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
