RISPERIDONE | A076288 | NATCO PHARMA USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mylan Pharmaceuticals, Inc. FDA-2006-P-0203 Mylan Pharmaceuticals Inc. filed this citizen petition requesting that FDA award Mylan 180-day generic marketing exclusivity for its ANDA for risperidone tablets in six strengths (0.25mg, 0.5mg, 1mg, 2mg, 3mg, and 4mg), arguing that exclusivity eligibility should be determined by the date notice of | Other | 2008-06-19 | Denied | Mylan Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.