LEUCOVORIN CALCIUM | A040347 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Epic Pharma, LLC FDA-2024-P-4494 Epic Pharma, LLC requests that the FDA Commissioner determine whether Leucovorin Calcium Injection, Eq 10 mg Base/mL (ANDA 040347) held by Hikma Pharmaceuticals USA Inc. was voluntarily withdrawn or withdrawn for safety or effectiveness reasons under Section 505(j)(2)(C) of the FD&C Act and 21 CFR 3 | 505(q) | 2024-09-26 | Withdrawn | Epic Pharma |
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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