DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | N017451 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2018-P-0964 · 5 docket documents Fresenius Kabi USA, LLC filed this citizen petition on March 2, 2018, requesting that the FDA determine whether the NDA holder for Plasma-Lyte 148 and Dextrose 5% (NDA 017451), originally held by Baxter Healthcare Corp., withdrew the product for reasons of safety or efficacy pursuant to 21 CFR 314.1 | 505(q) | 2018-03-05 | Denied | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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