BENZTROPINE MESYLATE | N012015 | EPIC PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nexus Pharmaceuticals FDA-2023-P-2055 Nexus Pharmaceuticals submitted this petition on May 19, 2023, requesting that the FDA Commissioner determine whether Cogentin (benztropine mesylate injection) under NDA 012015, held by Akorn Operating Co. LLC and listed as discontinued in the Orange Book, was voluntarily withdrawn from sale for saf | 505(q) | 2023-05-22 | Denied | Nexus Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.