DIAZEPAM | N013263 | WAYLIS THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Roxane Laboratories, Inc. FDA-1985-P-0507 Roxane Laboratories, Inc. filed this petition on December 5, 1985, requesting that the FDA determine whether Diazepam Intensol (Concentrated Oral Solution) 5 mg per ml is suitable for an ANDA application, positioning it as similar to the listed drug Valium Tablets 5 mg and arguing that the concentra | 505(q) | 2026-02-09 | Granted | Roxane Laboratories |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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