LEUCOVORIN CALCIUM | A207226 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Epic Pharma, LLC FDA-2024-P-1441 Epic Pharma, LLC submitted a suitability petition under 21 C.F.R. § 314.93 requesting FDA approval to file an ANDA for Leucovorin Calcium Injection in new strengths of 200 mg(base)/20 mL and 350 mg(base)/35 mL and in a ready-to-use injectable dosage form, arguing that the proposed product raises no | Suitability | 2024-03-25 | Open | Epic Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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