ANDA 213797, held by Quagen. Levoleucovorin Calcium.
As of Nov 15, 2026, ANDA 213797 (Levoleucovorin Calcium), held by Quagen, was first approved by FDA on Nov 2, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levoleucovorin CalciumEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) ยท solution;intravenous | Levoleucovorin Calcium | Discontinued |
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
