DIAZEPAM | N020648 | BAUSCH HEALTH US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Valeant Pharmaceuticals International (Valeant) FDA-2006-P-0009 Valeant Pharmaceuticals International filed this petition on September 22, 2006, pursuant to section 505 of the Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) for diazepam rectal gel products referencing the withdrawn fixed-do | 505(q) | 2008-08-13 | Denied | Valeant Pharmaceuticals International (Valeant) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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