NISOLDIPINE | A091001 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Emcure Pharmaceuticals USA, Inc FDA-2014-P-0549 Emcure Pharmaceuticals USA, Inc. filed this citizen petition on April 28, 2014, requesting that the FDA determine that Shionogi, Inc. discontinued marketing SULAR (nisoldipine) extended-release tablets 25.5 mg under NDA 20-356 for reasons unrelated to safety and efficacy, and that the FDA permit Emc | 505(q) | 2014-05-07 | Denied | Emcure Pharmaceuticals USA |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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