GENTAMICIN SULFATE | A062307 | PADAGIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Quagen Pharmaceuticals LLC FDA-2025-P-4045 · 3 docket documents Quagen Pharmaceuticals LLC filed this petition under section 505(j) of the FDC Act requesting that the FDA designate Gentamicin Sulfate Topical Cream, Eq to 0.1% Base manufactured by PADAGIS US LLC (ANDA 062307) as a Reference Listed Drug in the Orange Book, as the product is currently listed only a | 505(q) | 2025-09-19 | Withdrawn | Quagen Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.8813
per gm
Lowest NADAC/Unit
$0.8667
per gm
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 45802005635GENTAMICIN 0.1% CREAM | $0.8813 | GM | Generic | — | 2026-06-17 |
| 45802005611GENTAMICIN 0.1% CREAM | $0.8667 | GM | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.