ANDA 91115, held by Tamarang. Rocuronium Bromide.
As of Nov 13, 2026, ANDA 91115 (Rocuronium Bromide), held by Tamarang, was first approved by FDA on Aug 27, 2012, 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 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 27, 2012 | 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 29, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 1, 2018 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 27, 2012 | 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
