CEFTRIAXONE SODIUM | A090057 | SAMSON MEDICAL TECHNOLOGIES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Samson Medical Technologies, LLC FDA-2025-P-1030 · 7 docket documents 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 · 7 docket documents 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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