BALSALAZIDE DISODIUM | N020610 | VALEANT PHARMACEUTICALS INTERNATIONAL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Salix Pharmaceuticals, Inc. FDA-2005-P-0314 · 9 docket documents Salix Pharmaceuticals, Inc. filed this petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA establish guidance or regulations providing bioequivalence requirements for oral locally-acting gastrointestinal drug products prior to approval of generic version | 505(q) | 2011-03-10 | Denied | Salix Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.