NDA 215143, held by Hikma. Succinylcholine Chloride.
As of Nov 14, 2026, NDA 215143 (Succinylcholine Chloride), held by Hikma, was first approved by FDA on Aug 20, 2021, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Succinylcholine Chloride100MG/5ML (20MG/ML) · solution;intramuscular, intravenous | Succinylcholine Chloride | DiscontinuedReference drug |
| Nov 1, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Jul 22, 2022 | Supplement 2Manufacturing | Tentative approval | |
| Mar 17, 2022 | Supplement 1Labeling · Standard review | Approved | |
| Aug 20, 2021 | 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
