Treats hypocalcemia in those conditions requiring a prompt increase in plasma calcium…. ANDA 203477, held by Intl Medication Sys. Calcium Chloride.
As of Nov 15, 2026, ANDA 203477 (Calcium Chloride 10%), held by Intl Medication Sys, was first approved by FDA on May 9, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE 10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcium Chloride 10%100MG/ML · injectable;injection | Calcium Chloride | Rx |
| Jul 1, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 9, 2018 | Original application | Approved | None posted |
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
