METFORMIN HYDROCHLORIDE | A211309 | SAPTALIS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bionpharma, Inc. FDA-2023-P-5687 Bionpharma, Inc. filed a citizen petition requesting that the FDA make a determination that RIOMET (Metformin Hydrochloride) Oral Solution, 500 mg/5mL, approved under NDA 021591, was not discontinued or withdrawn from sale for reasons of safety or effectiveness. This determination is necessary to en | 505(q) | 2023-12-27 | Denied | Bionpharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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