HEPARIN SODIUM | N017029 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BE Pharmaceuticals AG FDA-2022-P-2952 BE Pharmaceuticals AG submitted this citizen petition on October 18, 2022, requesting that the FDA determine whether Heparin sodium injection, 5000 USP Units/mL manufactured by Fresenius Kabi USA LLC and approved under NDA 017029 was withdrawn from sale for reasons related to safety or effectiveness | 505(q) | 2022-11-21 | Denied | BE Pharmaceuticals AG |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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