ANDA 217034, held by Hikma. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 217034 (Rocuronium Bromide), held by Hikma, was first approved by FDA on May 24, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rocuronium Bromide50MG/5ML (10MG/ML) ยท injectable;injection | Rocuronium Bromide | Discontinued |
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
