AMOXICILLIN; VONOPRAZAN FUMARATE | N215153 | PHATHOM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Phathom Pharmaceuticals, Inc. FDA-2024-P-5703 · 7 docket documents 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
$7.48
per ea
Lowest NADAC/Unit
$7.48
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 81520025014VOQUEZNA DUAL PAK | $7.48 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.