CEFTRIAXONE SODIUM | A090057 | SAMSON MEDICAL TECHNOLOGIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Samson Medical Technologies, LLC FDA-2025-P-1030 Samson Medical Technologies, LLC filed this citizen petition pursuant to 21 CFR 314.93 requesting FDA approval to file an Abbreviated New Drug Application for Ceftriaxone for Injection, USP in a 300 gram pharmacy bulk package, which differs from the reference listed drug Rocephin 10 gram pharmacy bu | Suitability | 2025-04-03 | Open | Samson Medical Technologies |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.