SIMVASTATIN | N019766 | ORGANON LLC A SUB OF ORGANON AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals Inc FDA-2006-P-0272 Teva Pharmaceuticals USA, Inc. filed this document on October 21, 2005, withdrawing its previously submitted comments in response to citizen petitions filed by Ivax Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited regarding the delisting of patents from the Orange Book for generic simvastatin | 505(q) | 2009-04-01 | Open | Zydus Pharmaceuticals Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.