VORICONAZOLE | N021630 | PF PRISM CV
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 RLD -VFEND Label from drugsfda - version August 2022-1re Suitabi... FDA-2023-P-5094 · 10 docket documents This petition from Cardinal Health Regulatory Sciences requests FDA suitability assessment for voriconazole products referencing the RLD VFEND, with the submission including the August 2022 version of the VFEND label from the FDA's drugs database. | Suitability | 2023-11-17 | Granted | Cardinal Health Regulatory Sciences |
Attachment 4 - Letter from FDA about Model Labeling for RLD (VFEND) RE Suitab... FDA-2021-P-0342 · 10 docket documents Cardinal Health Regulatory Sciences filed a suitability petition requesting FDA approval of model labeling for VFEND (voriconazole), the reference listed drug, to establish appropriate labeling standards for generic versions of this antifungal medication. The petition sought to facilitate the develo | Suitability | 2021-03-31 | Withdrawn | Cardinal Health Regulatory Sciences |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.49
per ml
Lowest NADAC/Unit
$5.49
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59762093503VORICONAZOLE 40 MG/ML SUSP | $5.49 | ML | 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.