NDA 215668, held by Dr Reddys Labs Ltd. Bendamustine Hydrochloride.
As of Nov 13, 2026, NDA 215668 (Bendamustine Hydrochloride), held by Dr Reddys Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 12, 2021 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bendamustine Hydrochloride100MG/4ML (25MG/ML) · solution;intravenous | Bendamustine Hydrochloride | None (tentative approval) |
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
