Treats acute symptomatic hypocalcemia. ANDA 213071, held by Nivagen. Calcium Gluconate.
As of Nov 15, 2026, ANDA 213071 (Calcium Gluconate), held by Nivagen, was first approved by FDA on Oct 14, 2022, with 0 approved supplements and 0 published complete response letters.
Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate Injection for long term use has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 2022 | Original application | Approved |
| Calcium Gluconate1GM/10ML (100MG/ML) · solution;intravenous | Calcium Gluconate | Rx |
| Calcium Gluconate5GM/50ML (100MG/ML) · solution;intravenous | Calcium Gluconate | Rx |
| Calcium Gluconate10GM/100ML (100MG/ML) · solution;intravenous | Calcium Gluconate | 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
