NDA 20140, held by Acrotech Biopharma. Levoleucovorin Calcium.
As of Nov 13, 2026, NDA 20140 (Fusilev), held by Acrotech Biopharma, was first approved by FDA on Mar 7, 2008, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2011 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 7, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FusilevEQ 50MG BASE/VIAL · powder;intravenous | Levoleucovorin Calcium | DiscontinuedReference drug |
| FusilevEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Levoleucovorin Calcium | DiscontinuedReference drug |
| FusilevEQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Levoleucovorin Calcium | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2020 | Supplement 26Labeling · Standard review | Approved | |
| Feb 11, 2020 | Supplement 25Labeling · Standard review | Approved | |
| Jan 8, 2020 | Supplement 24Labeling · Standard review | Approved | |
| Jun 24, 2014 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 9, 2012 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 29, 2011 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 14, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Mar 7, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
