LEUCOVORIN CALCIUM | N018459 | XANODYNE PHARMACEUTICS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 Suitability Petition Approval Letters for Leucovorin Calcium Inj... FDA-2024-P-1441 · 13 docket documents 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 | Suitability | 2024-03-25 | Granted | — |
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for Leucovorin Calcium Injection, a ready-to-use sterile solution in a 50 mL pharmacy bulk packa | Other | 2019-05-01 | Withdrawn | Abbott Laboratories |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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