ROCURONIUM BROMIDE | N020214 | ORGANON USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Citizen Petition from Lachman Consultant Services Inc. FDA-2021-P-0784 Lachman Consultant Services Inc. filed this petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Rocuronium Bromide Injection, 20 mg/2 mL single dose prefilled syringe suitable for submission as an ANDA based on the reference listed drug ZEM | Suitability | 2021-07-23 | Open | Lachman Consultant Services Inc. |
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in two strengths, because the currently selected reference standard ANDA 079195 has limited | 505(q) | 2018-02-12 | Withdrawn | Prinston Pharmaceutical Inc. |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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