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 | Granted | Samson Medical Technologies, LLC |
Suitability Petition from On Demand Pharmaceuticals, Inc. FDA-2024-P-5184 On Demand Pharmaceuticals, Inc. submitted a suitability petition under 21 CFR 314.93 requesting FDA permission to file an ANDA under Section 505(j) for Cisatracurium Besylate for Injection in a 500 mg/250 ml Pharmacy Bulk Package bag, which differs from the reference listed drug Nimbex (NDA 020551, | Suitability | 2024-11-05 | Granted | On Demand Pharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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