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whether Leucovorin Calcium For Oral Solution, EQ 60 mg base/vial (NDA 008107), held by Hospira Inc., was voluntarily withdrawn from sale for reasons of safety or efficacy.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Leucovorin Calcium Injection, Eq 10 mg Base/mL (ANDA 040347) held by Hikma Pharmaceuticals USA Inc. was voluntarily withdrawn or withdrawn for safety or effectiveness reasons under Section 505(j)(2)(C) of the FD&C Act and 21 CFR 3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

Epic Pharma, LLC submitted a suitability petition under 21 C.F.R. §314.93(b) requesting permission to submit an Abbreviated New Drug Application for Leucovorin Calcium Injection in two strengths (200 mg/20 ml and 350 mg/35 ml). The FDA determined the petition complete and established an October 5, 2

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

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-1997-P-0357

Gensia Laboratories, Inc. filed an ANDA suitability petition under Section 505(j)(2)(c) requesting approval to submit an abbreviated new drug application for Leucovorin Calcium Injection in a 300 mg strength, 10 mg/ml ready-to-use liquid formulation, which differs in strength and dosage form from th

FDA-1997-P-0357

Gensia Laboratories Ltd. filed this ANDA suitability petition on December 2, 1997, under Federal Food, Drug, and Cosmetic Act Section 505(j)(2)(c) and 21 CFR 314.93(d), requesting permission to submit an abbreviated new drug application for a 500 mg, 10 mg/ml ready-to-use liquid Leucovorin Calcium I

FDA-1997-P-0303

Bigmar Incorporated submitted a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to file an abbreviated new drug application for a 500 mg lyophilized Leucovorin Calcium for injection product that, when reconstituted with 25 mL of diluent

FDA-1997-P-0303

Bigmar, Inc. submitted a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting permission to file an abbreviated new drug application (ANDA) for a 500 mg lyophilized Leucovorin Calcium for Injection product that when reconstituted with 50 mL of diluent wou

FDA-1991-P-0051

Cetus Corporation submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act on June 19, 1991, requesting permission to file an abbreviated new drug application for a 200 mg lyophilized Leucovorin Calcium for Injection product that, when reconstituted with

FDA-1993-P-0178

Abbott Laboratories' Hospital Products Division filed this ANDA suitability petition under Section 505(j)(2)(c) requesting approval to submit an abbreviated new drug application for Leucovorin Calcium Injection as a ready-to-use sterile solution in a 10 mL vial containing 100 mg, representing a chan

FDA-1993-P-0178

Abbott Laboratories filed this ANDA Suitability Petition under Federal Food, Drug and Cosmetic Act Section 505(j)(2)(c) requesting approval to submit an abbreviated new drug application for Leucovorin Calcium Injection, a ready-to-use sterile solution of 250 mg (10 mg/mL) in a 25 mL single-dose vial

FDA-1993-P-0178

Abbott Laboratories filed this citizen petition under Federal Food, Drug and Cosmetic Act Section 505(b)(2)(c) and CFR 314.93(d) requesting permission to submit an abbreviated new drug application (ANDA) for Leucovorin Calcium Injection, a ready-to-use sterile solution in a 50 mL pharmacy bulk packa

FDA-2014-P-0251

Gordon Johnston Regulatory Consultants, LLC filed this citizen petition on behalf of a client requesting that the FDA declare Leucovorin Calcium Injection USP in strengths of 50 mg/5 mL, 200 mg/20 mL, and 350 mg/35 mL suitable for submission in an abbreviated new drug application (ANDA) under Sectio