ZONISAMIDE | N020789 | ADVANZ PHARMA (US) CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Unichem Pharmaceuticals (USA), Inc. FDA-2019-P-0076 Unichem Pharmaceuticals (USA) Inc. filed this citizen petition on December 28, 2018, requesting that the FDA determine whether the 50 mg strength of Sunovion Pharmaceuticals' ZONEGRAN (zonisamide) Capsules, approved under NDA N020789, was discontinued for safety or effectiveness reasons, and if not, | 505(q) | 2019-01-07 | Denied | Unichem Pharmaceuticals (USA) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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