FOSAPREPITANT DIMEGLUMINE | N210064 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceuticals USA, Inc FDA-2019-P-4155 Teva Pharmaceuticals USA, Inc. filed this petition requesting that the FDA assign a Therapeutic Equivalence Evaluation Code of "AP" in the Orange Book for Teva's Fosaprepitant Dimeglumine for Injection, Eq. 150 mg base/vial, which was approved under NDA 210064 on September 5, 2019, claiming it is ph | Other | 2019-09-06 | Denied | Teva Pharmaceuticals USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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