Treats metastatic colorectal cancer. ANDA 217314, held by Hainan Poly Pharm. Levoleucovorin Calcium.
As of Nov 15, 2026, ANDA 217314 (Levoleucovorin Calcium), held by Hainan Poly Pharm, was first approved by FDA on May 22, 2023, with 0 approved supplements and 0 published complete response letters.
Levoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use: Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12, because of the risk of progression of neurologic manifestations despite hematologic remission.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2023 | Original application | Approved | None posted |
| 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 | Rx |
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
