Treats indolent B-cell non-Hodgkin lymphoma. NDA 215033, held by Apotex. Bendamustine Hydrochloride.
As of Nov 14, 2026, NDA 215033 (Bendamustine Hydrochloride), held by Apotex, was first approved by FDA on Dec 7, 2022, with 1 approved supplement and 0 published complete response letters.
Non-Hodgkin Lymphoma (NHL) Bendamustine hydrochloride injection is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 7, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bendamustine Hydrochloride100MG/4ML (25MG/ML) · solution;intravenous | Bendamustine Hydrochloride | RxReference drug |
| Apr 15, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Dec 7, 2022 | 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
