ROCURONIUM BROMIDE | A079195 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Prinston Pharmaceutical Inc. FDA-2018-P-0664 Prinston Pharmaceutical Inc. filed this citizen petition requesting that the FDA amend the Orange Book to designate ANDA 091115, held by TAMARANG SA, as the reference standard for Rocuronium Bromide Injection in two strengths, because the currently selected reference standard ANDA 079195 has limited | 505(q) | 2018-02-12 | Withdrawn | Prinston Pharmaceutical Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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