DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | N018365 | OTSUKA ICU MEDICAL LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2019-P-4523 · 5 docket documents Fresenius Kabi USA, LLC filed this citizen petition on September 26, 2019, requesting that the FDA Commissioner determine whether potassium chloride in multiple strengths (5 mEq through 40 mEq) in dextrose 5% and sodium chloride 0.225% in plastic containers under NDA 018365 held by ICU Medical Inc. | 505(q) | 2019-09-27 | Denied | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.