ANDA 204679, held by West Ward Pharm Corp. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 204679 (Rocuronium Bromide), held by West Ward Pharm Corp, was first approved by FDA on Feb 28, 2017, with 3 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 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 |
|---|---|---|---|
| Feb 28, 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 |
|---|---|---|---|
| Jun 24, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 16, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 4, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 28, 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
