NDA 22303, held by Cephalon. Bendamustine Hydrochloride.
As of Nov 13, 2026, NDA 22303 (Treanda), held by Cephalon, was first approved by FDA on Oct 31, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2008 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Treanda100MG · injectable; injection | Bendamustine Hydrochloride | 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