DAPRODUSTAT | N216951 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Qilu Pharmaceutical (Hainan) Co., Ltd. FDA-2024-P-3482 Qilu Pharmaceutical (Hainan) Co., Ltd. filed this citizen petition requesting that the FDA determine whether JESDUVROQ (daprodustat) tablets in strengths of 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, approved under NDA 216951 and held by GlaxoSmithKline Intellectual Property No 2 Ltd England, was voluntarily | 505(q) | 2024-07-25 | Withdrawn | Qilu Pharmaceutical (Hainan) Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.