AMOXICILLIN; VONOPRAZAN FUMARATE | N215153 | PHATHOM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Phathom Pharmaceuticals, Inc. FDA-2024-P-5703 Phathom Pharmaceuticals, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA correct the Orange Book to accurately reflect a full ten-year period of new chemical entity exclusivity for VOQUEZNA (vonoprazan tablets, approved under NDA | 505(q) | 2024-12-11 | Granted | Phathom Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$7.50
per ea
Lowest NADAC/Unit
$7.50
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 81520025014VOQUEZNA DUAL PAK | $7.50 | EA | Brand | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.