DIAZEPAM | A071415 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Roxane Laboratories, Inc. FDA-1985-P-0507 · 4 docket documents 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, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9969
per ml
Lowest NADAC/Unit
$0.9969
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054318544DIAZEPAM 5 MG/ML ORAL CONC | $0.9969 | ML | Generic | — | 2026-05-20 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.