NDA 211530, held by Hospira. Bendamustine Hydrochloride.
As of Nov 13, 2026, NDA 211530 (Bendamustine Hydrochloride), held by Hospira, was first approved by FDA on Dec 15, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bendamustine Hydrochloride25MG/ML (25MG/ML) · solution;intravenous | Bendamustine Hydrochloride | DiscontinuedReference drug |
| Bendamustine Hydrochloride100MG/4ML (25MG/ML) · solution;intravenous | Bendamustine Hydrochloride | DiscontinuedReference drug |
| Bendamustine Hydrochloride200MG/8ML (25MG/ML) · solution;intravenous | Bendamustine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Dec 15, 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
