CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | N018883 | FRESENIUS MEDICAL CARE NORTH AMERICA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Medical Care North America FDA-2019-P-2853 · 4 docket documents Fresenius Medical Care North America filed this citizen petition on June 11, 2019, requesting that the FDA designate NDA 018883 and NDA 020171 as Reference Listed Drug and Reference Standard status in the Orange Book for Delflex peritoneal dialysis solutions containing dextrose at various concentrat | Other | 2019-06-13 | Granted | Fresenius Medical Care North America |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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