ANDA 210437, held by Piramal Critical. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 210437 (Rocuronium Bromide), held by Piramal Critical, was first approved by FDA on Aug 13, 2019, with 0 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 |
|---|---|---|---|
| Aug 13, 2019 | 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 |
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
