NDA 18342, held by Glaxosmithkline. Leucovorin Calcium.
As of Nov 13, 2026, NDA 18342 (Wellcovorin), held by Glaxosmithkline, was first approved by FDA on Jul 8, 1983, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2026 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Jul 8, 1983 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| WellcovorinEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Leucovorin Calcium | DiscontinuedReference drug |
| WellcovorinEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Leucovorin Calcium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2026 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Jun 6, 1996 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 14, 1993 | Supplement 8Labeling | Approved | None posted |
| Jul 8, 1983 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
