ANDA 203563, held by Sandoz. Levoleucovorin Calcium.
As of Nov 15, 2026, ANDA 203563 (Levoleucovorin Calcium), held by Sandoz, was first approved by FDA on Mar 9, 2015, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 9, 2015 | Original application | Approved |
| Levoleucovorin CalciumEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) · solution;intravenous | Levoleucovorin Calcium | Rx |
| Levoleucovorin CalciumEQ 250MG BASE/25ML (EQ 10MG BASE/ML) · solution;intravenous | Levoleucovorin Calcium | Discontinued |
| Jan 6, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 9, 2015 | Original application | 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
