LEUCOVORIN CALCIUM | N008107 | HOSPIRA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc. FDA-2026-P-0749 · 5 docket documents 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whether Leucovorin Calcium For Oral Solution, EQ 60 mg base/vial (NDA 008107), held by Hospira Inc., was voluntarily withdrawn from sale for reasons of safety or efficacy.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 | 505(q) | 2026-01-26 | Granted | Apotex Inc. |
Citizen Petition from Epic Pharma, LLC FDA-2024-P-4494 · 6 docket documents 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Leucovorin Calcium Injection, Eq 10 mg Base/mL (ANDA 040347) held by Hikma Pharmaceuticals USA Inc. was voluntarily withdrawn or withdrawn for safety or effectiveness reasons under Section 505(j)(2)(C) of the FD&C Act and 21 CFR 3 | 505(q) | 2024-09-26 | Withdrawn | Epic Pharma, LLC |
Suitability Petition from Epic Pharma, LLC FDA-2024-P-1441 · 13 docket documents 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 | Granted | Epic Pharma, LLC |
Suitability Petition from Gensia Laboratories Ltd. FDA-1997-P-0357 · 8 docket documents 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 | Suitability | 2023-10-31 | Granted | Gensia Laboratories Ltd. |
Citizen petition from Bigmar Inc. FDA-1997-P-0303 · 8 docket documents 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 | Other | 2019-07-16 | Granted | Bigmar Inc. |
Citizen Petition from Cetus Corporation FDA-1991-P-0051 · 4 docket documents 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 | Other | 2019-05-07 | Granted | Cetus Corporation |
Citizen Petition from Abbott Laboratories FDA-1993-P-0178 · 12 docket documents 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 | Other | 2019-05-01 | Withdrawn | Abbott Laboratories |
Citizen Petition From Gordon Johnston Regulatory Consultants, LLC FDA-2014-P-0251 · 3 docket documents 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 | Other | 2014-03-07 | Open | Gordon Johnston Regulatory Consultants, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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