PHYTONADIONE | A209373 | AMNEAL PHARMACEUTICALS CO GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axinn on behalf of Zydus Pharmaceuticals (USA) Inc. FDA-2019-P-2240 · 10 docket documents Axinn, on behalf of Zydus Pharmaceuticals (USA) Inc., filed this citizen petition pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act requesting that the FDA require manufacturers of Phytonadione Tablets ANDAs referencing Mephyton (NDA No. 010104) to provide data demonstrating compara | 505(q) | 2019-05-09 | Partially Denied | Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.38
per ea
Lowest NADAC/Unit
$9.38
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 60687038194PHYTONADIONE 5 MG TABLET | $9.38 | EA | Generic | — | 2026-06-17 |
| 69238105103PHYTONADIONE 5 MG TABLET | $9.38 | EA | Generic | — | 2026-06-17 |
| 00904688210PHYTONADIONE 5 MG TABLET | $9.38 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.