AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE | N215152 | 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.