BROMFENAC SODIUM | A203395 | SENTISS AG
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Regcon Solutions LLC FDA-2015-P-2962 Regcon Solutions LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Hi-Tech Pharmacal's Bromfenac Sodium ophthalmic solution 0.09% acid (ANDA 203395) as a second reference listed drug, since the | 505(q) | 2015-08-12 | Withdrawn | Regcon Solutions LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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