VORICONAZOLE | N208562 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps, & McNamara, P.C. FDA-2017-P-3329 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of Xellia Pharmaceutical ApS and Xellia Pharmaceuticals USA, LLC requesting that FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for Xellia's Voriconazole for Injection, 200 mg/vial, approved under NDA 20856 | Other | 2017-05-30 | Granted | Hyman, Phelps, & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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