LEUCOVORIN CALCIUM

FDA-2026-P-0749

Apotex Inc. filed a citizen petition requesting that the FDA determine whether Leucovorin Calcium For Oral Solution, EQ 60 mg base/vial (NDA 008107), held by Hospira Inc., was voluntarily withdrawn from sale for reasons of safety or efficacy. This determination is necessary under 21 CFR 314.161 befo

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Leucovorin Calcium Injection, Eq 10 mg Base/mL (ANDA 040347) held by Hikma Pharmaceuticals USA Inc. was voluntarily withdrawn or withdrawn for safety or effectiveness reasons under Section 505(j)(2)(C) of the FD&C Act and 21 CFR 3

FDA-2024-P-1441

I have reviewed the document you provided. However, it appears to contain only a title reference to "Attachment 3 Suitability Petition Approval Letters for Leucovorin Calcium Injection" without the substantive content of the citizen petition itself. To provide an accurate summary meeting your speci

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