NDA 208791, held by B Braun Medical. Chloroprocaine Hydrochloride.
As of Nov 15, 2026, NDA 208791 (Clorotekal), held by B Braun Medical, was first approved by FDA on Sep 26, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clorotekal50MG/5ML (10MG/ML) · solution;intrathecal | Chloroprocaine Hydrochloride | DiscontinuedReference 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
