ARGATROBAN | N203049 | HIKMA PHARM CO LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AuroMedics Pharma LLC FDA-2019-P-2687 AuroMedics Pharma LLC, the U.S. agent for Aurobindo Pharma Limited, filed this citizen petition on June 3, 2019, requesting that the FDA assign a therapeutic equivalence rating of AP to Aurobindo's Argatroban in Sodium Chloride Injection, 50 mg/50 mL, approved under 505(b)(2) NDA 209552, relative to | 505(q) | 2019-06-04 | Withdrawn | AuroMedics Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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