GENTAMICIN SULFATE | A062307 | PADAGIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Quagen Pharmaceuticals LLC FDA-2025-P-4045 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as a Reference Listed Drug in the Orange Book, as the product is currently listed only a | 505(q) | 2025-09-19 | Withdrawn | Quagen Pharmaceuticals LLC |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.
No patent or exclusivity listings for this strength.