METHYLERGONOVINE MALEATE | N006035 | EDISON THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Gland Pharma Limited FDA-2025-P-6392 Gland Pharma Limited filed this citizen petition requesting that the FDA determine whether Methergine (methylergonovine maleate) Injection, 0.2 mg/mL (NDA #006035), held by Edison Therapeutics LLC, was voluntarily withdrawn from sale for reasons of safety or effectiveness. The determination is neces | 505(q) | 2025-11-21 | Withdrawn | Gland Pharma Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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