CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE | N017390 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2018-P-0967 · 5 docket documents Fresenius Kabi USA, LLC filed this petition on March 2, 2018, requesting that the FDA determine whether Plasma-Lyte M and Dextrose 5% (NDA 017390), a listed drug product held by Baxter Healthcare Corp, was voluntarily withdrawn from sale for reasons of safety or efficacy, as required under 21 CFR 31 | 505(q) | 2018-03-05 | Denied | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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