Treats potassium deficiency states. ANDA 214727, held by Nexus. Potassium Chloride.
As of Nov 15, 2026, ANDA 214727 (Potassium Chloride 10meq, Potassium Chloride 20meq, Potassium Chloride 40meq), held by Nexus, was first approved by FDA on Mar 18, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2021 | Original application | Approved |
| Potassium Chloride 10meq14.9MG/ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 10meq745MG/100ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 20meq29.8MG/ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 20meq1.49GM/100ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 40meq2.98GM/100ML · injectable;injection | Potassium Chloride | 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
