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 · 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.
Highest NADAC/Unit
$9.73
per ea
Lowest NADAC/Unit
$9.73
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 78206018201ZOCOR 40 MG TABLET | $9.73 | EA | Brand | $0.0534 | 2026-01-01 |
| 78206018202ZOCOR 40 MG TABLET | $9.73 | EA | Brand | $0.0534 | 2026-01-01 |
| 78206018101ZOCOR 20 MG TABLET | $9.73 | EA | Brand | $0.0297 | 2026-01-01 |
| 78206018102ZOCOR 20 MG TABLET | $9.73 | EA | Brand | $0.0297 | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.