FOSAPREPITANT DIMEGLUMINE | A206197 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Baxter Healthcare Corporation FDA-2017-P-4670 · 9 docket documents Baxter Healthcare Corporation filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Merck's EMEND (fosaprepitant dimeglumine) 150 mg/vial, approved under NDA 022023, was reformulated for safety or effe | 505(q) | 2017-08-03 | Granted | Baxter Healthcare Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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