SIMVASTATIN | N021961 | SYNTHON PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals Inc FDA-2006-P-0272 · 4 docket documents 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 |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2006-P-0398 · 4 docket documents 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.
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