SIMVASTATIN | A076685 | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2006-P-0398 Zydus Pharmaceuticals (USA) Inc. filed this citizen petition on June 16, 2006, requesting that the FDA provide tentative approval and full approval of ANDA No. 77-837 for simvastatin tablets (5, 10, 20, 40, and 80 mg) upon the June 23, 2006 expiration of U.S. Patent No. 4,444,784, arguing that the p | 505(q) | 2009-04-01 | Open | Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.