Treats acute symptomatic hypocalcemia. ANDA 216541, held by B Braun Medical. Calcium Gluconate.
As of Nov 15, 2026, ANDA 216541 (Calcium Gluconate), held by B Braun Medical, was first approved by FDA on Aug 21, 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 |
|---|---|---|---|
| Aug 21, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| 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
