Treats megaloblastic anemias due to folic acid deficiency. Sold as Leucovorin Calcium, Wellcovorin, Vykoura. Every FDA application for this active ingredient: 4 branded and 55 generic.
As of Nov 15, 2026, FDA lists 59 applications for Leucovorin Calcium (sold as Leucovorin Calcium, Wellcovorin, Vykoura), first approved Jun 20, 1952, with 5 new uses approved and 0 published complete response letters.
| Leucovorin Calcium | Part D | $5.8M | +19% | 30,782 |
| Leucovorin Calcium | Part B | $4.6M | -21% | 13,214 |
| Jun 20, 1952 | Leucovorin CalciumNDA 8107 · New molecular entity | Hospira | 36 | Discontinued |
| Feb 8, 1980 | Leucovorin CalciumNDA 18459 | Xanodyne Pharm | 10 | Discontinued |
| Jul 8, 1983 | WellcovorinNDA 18342 · New dosage form | Glaxosmithkline | 3 | Discontinued |
| Jan 2, 1987 | Leucovorin CalciumANDA 70480 | Elkins Sinn | 17 | Discontinued |
| Mar 4, 1987 | Leucovorin CalciumANDA 71104 | Xanodyne Pharm | 6 | Discontinued |
| Sep 14, 1987 | Leucovorin CalciumANDA 89384 | Hikma | 16 | Marketed |
| Sep 24, 1987 | Leucovorin CalciumANDA 71198 | Barr | 29 | Marketed |
| Sep 24, 1987 | Leucovorin CalciumANDA 71199 | Barr | 18 | Marketed |
| Nov 19, 1987 | Leucovorin CalciumANDA 71962 | Xanodyne Pharm | 8 | Discontinued |
| Mar 28, 1988 | Leucovorin CalciumANDA 89717 | Hikma | 13 | Marketed |
| Feb 22, 1993 | Leucovorin CalciumANDA 72734 | Hikma | 8 | Marketed |
| Feb 22, 1993 | Leucovorin CalciumANDA 72736 | Hikma | 8 | Marketed |
| Feb 22, 1993 | Leucovorin CalciumANDA 72733 | Hikma | 8 | Marketed |
| Feb 22, 1993 | Leucovorin CalciumANDA 72735 | Hikma | 8 | Marketed |
| Sep 28, 1993 | Leucovorin CalciumANDA 81277 | Teva Pharms USA | 7 | Discontinued |
| Sep 28, 1993 | Leucovorin CalciumANDA 81278 | Teva Parenteral | 4 | Discontinued |
| Jun 3, 1994 | Leucovorin CalciumANDA 81224 | Elkins Sinn | 3 | Discontinued |
| May 23, 1995 | Leucovorin Calcium Preservative FreeANDA 40056 | Hikma | 5 | Marketed |
| Mar 28, 1997 | Leucovorin CalciumANDA 73099 | Pharmachemie | 1 | Discontinued |
| Mar 28, 1997 | Leucovorin CalciumANDA 73101 | Pharmachemie | 1 | Discontinued |
| Apr 17, 1997 | Leucovorin CalciumANDA 89628 | Pharmachemie USA | 3 | Discontinued |
| Apr 17, 1997 | Leucovorin CalciumANDA 89915 | Pharmachemie USA | 3 | Discontinued |
| Jun 12, 1997 | Leucovorin CalciumANDA 40174 | Teva Pharms USA | 4 | Discontinued |
| Jun 25, 1997 | Leucovorin Calcium Preservative FreeANDA 40147 | Hospira | 2 | Discontinued |
| Aug 28, 1997 | Leucovorin CalciumANDA 74544 | Epic Pharma LLC | 1 | Marketed |
| Feb 26, 1999 | Leucovorin Calcium Preservative FreeANDA 40258 | Fresenius Kabi USA | 1 | Marketed |
| Feb 26, 1999 | Leucovorin Calcium Preservative FreeANDA 40286 | Fresenius Kabi USA | 1 | Marketed |
| Mar 24, 1999 | Leucovorin CalciumANDA 75327 | Ani Pharms | 3 | Discontinued |
| Jun 28, 1999 | Leucovorin Calcium Preservative FreeANDA 40332 | Teva Parenteral | 0 | Discontinued |
| Dec 15, 1999 | Leucovorin CalciumANDA 40262 | Pharmachemie | 0 | Discontinued |
| Apr 20, 2000 | Leucovorin Calcium Preservative FreeANDA 40335 | Hikma | 1 | Marketed |
| Apr 25, 2000 | Leucovorin Calcium Preservative FreeANDA 40347 | Hikma | 2 | Discontinued |
| Jan 31, 2001 | Leucovorin Calcium Preservative FreeANDA 40338 | Am Regent | 0 | Discontinued |
| Sep 6, 2012 | Leucovorin Calcium Preservative FreeANDA 200855 | Sagent Pharms | 0 | Marketed |
| Sep 6, 2012 | Leucovorin Calcium Preservative FreeANDA 200753 | Sagent Pharms | 0 | Marketed |
| May 19, 2017 | Leucovorin Calcium Preservative FreeANDA 203800 | Mylan Labs Ltd | 0 | Marketed |
| Oct 26, 2017 | Leucovorin Calcium Preservative FreeANDA 209110 | Sagent Pharms Inc | 0 | Marketed |
| Mar 14, 2018 | Leucovorin CalciumANDA 207241 | Fresenius Kabi USA | 0 | Marketed |
| Jul 27, 2018 | Leucovorin CalciumANDA 207226 | Fresenius Kabi USA | 0 | Marketed |
| Nov 23, 2018 | Leucovorin CalciumANDA 210917 | Ingenus Pharms LLC | 0 | Discontinued |
| Jul 30, 2020 | Leucovorin CalciumANDA 211132 | Ingenus Pharms LLC | 1 | Marketed |
| Oct 22, 2020 | Leucovorin CalciumANDA 213929 | Leading | 1 | Marketed |
| Jul 10, 2023 | Leucovorin CalciumANDA 217021 | Hainan Poly | 0 | Marketed |
| Jul 19, 2023 | Leucovorin CalciumANDA 216590 | Meitheal | 2 | Marketed |
| Nov 12, 2025 | Leucovorin CalciumANDA 218200 | Gland | 1 | Marketed |
| Feb 3, 2026 | VykouraNDA 220406 · New formulation or manufacturer | Avyxa Holdings | 0 | Marketed |
| — | Leucovorin CalciumANDA 71598 | Par Pharm | 0 | Discontinued |
| — | Leucovorin CalciumANDA 71600 | Par Pharm | 0 | Discontinued |
| — | WellcovorinANDA 87439 | Glaxosmithkline | 0 | Discontinued |
| — | Leucovorin CalciumANDA 88939 | Abraxis Pharm | 0 | Discontinued |
| — | Leucovorin CalciumANDA 89352 | Abic | 0 | Discontinued |
| — | Leucovorin CalciumANDA 89353 | Abic | 0 | Discontinued |
| — | WellcovorinANDA 89465 | Glaxosmithkline | 0 | Discontinued |
| — | Leucovorin CalciumANDA 89496 | Quad Pharms | 0 | Discontinued |
| — | Leucovorin CalciumANDA 89503 | Quad Pharms | 0 | Discontinued |
| — | Leucovorin CalciumANDA 89504 | Quad Pharms | 0 | Discontinued |
| — | Leucovorin CalciumANDA 89636 | Quad Pharms | 0 | Discontinued |
| — | WellcovorinANDA 89833 | Glaxosmithkline | 0 | Discontinued |
| — | WellcovorinANDA 89834 | Glaxosmithkline | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Glaxosmithkline
Hikma
Fresenius Kabi USA
Mylan Labs Ltd
Par Pharm
Abraxis Pharm