DEXTROSE | N017521 | BAXTER HEALTHCARE CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC. FDA-2020-P-0678 · 5 docket documents Fresenius Kabi USA, LLC filed this citizen petition under 21 CFR 10.30 and 314.161 requesting that the FDA determine whether the NDA holder for Dextrose 70% (NDA 017521) in Plastic Containers withdrawn the product for reasons of safety or efficacy, as the product now appears in the discontinued sect | 505(q) | 2020-02-07 | Granted | Fresenius Kabi USA, LLC. |
Citizen Petition from Fresenius Kabi USA, LLC FDA-2019-P-0466 · 5 docket documents Fresenius Kabi USA, LLC filed a citizen petition pursuant to 21 CFR 10.30 and 314.161 requesting that the FDA determine whether Baxter Healthcare Corp. has withdrawn Dextrose 20% and Dextrose 50% in Plastic Containers (NDA 017521) for reasons of safety or efficacy, as these products currently appear | 505(q) | 2019-01-30 | Denied | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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