Treats acute symptomatic hypocalcemia. ANDA 217689, held by Somerset. Calcium Gluconate.
As of Nov 15, 2026, ANDA 217689 (Calcium Gluconate), held by Somerset, was first approved by FDA on Oct 19, 2023, 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 19, 2023 | Original application | Approved | None posted |
| 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
