BROMFENAC SODIUM | A210560 | ALEMBIC PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4359 Pharmobedient Consulting, LLC submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Bromfenac Solution/Drops, 0.08% suitable for submission in an Abbreviated New Drug Application, representing a strength change from th | Suitability | 2023-10-05 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.