ANDA 206206, held by Eugia Pharma. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 206206 (Rocuronium Bromide), held by Eugia Pharma, was first approved by FDA on Apr 12, 2017, with 2 approved supplements and 0 published complete response letters.
Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rocuronium Bromide50MG/5ML (10MG/ML) · injectable;injection | Rocuronium Bromide | Rx |
| Rocuronium Bromide100MG/10ML (10MG/ML) · injectable;injection | Rocuronium Bromide | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 26, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 12, 2017 | Original application | Approved | None posted |
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
