BROMFENAC SODIUM | A203395 | SENTISS AG
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Regcon Solutions LLC FDA-2015-P-2962 · 4 docket documents 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ophthalmic solution 0.09% acid (ANDA 203395) as a second reference listed drug, since the | 505(q) | 2015-08-12 | Withdrawn | Regcon Solutions LLC |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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