BORTEZOMIB | N215441 | ACCORD HEALTHCARE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Qilu Pharmaceutical (Hainan) Co., Ltd. FDA-2023-P-1549 Qilu Pharmaceutical (Hainan) Co., Ltd. filed this citizen petition on April 19, 2023, requesting that the FDA determine whether Bortezomib 2.5 mg/mL, approved under NDA 215441 and held by Accord Healthcare Inc., was discontinued or withdrawn for safety or effectiveness reasons. The petitioner conten | 505(q) | 2023-04-20 | Denied | Qilu Pharmaceutical (Hainan) Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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