Treats potassium deficiency states. ANDA 211087, held by Fresenius Kabi USA. Potassium Chloride.
As of Nov 15, 2026, ANDA 211087 (Potassium Chloride 10meq, Potassium Chloride 20meq, Potassium Chloride 40meq), held by Fresenius Kabi USA, was first approved by FDA on Sep 9, 2020, with 2 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 |
|---|---|---|---|
| Sep 9, 2020 | Original application | Approved |
| Potassium Chloride 10meq14.9MG/ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 10meq746MG/100ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 20meq29.8MG/ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 40meq2.98GM/100ML · injectable;injection | Potassium Chloride | Rx |
| Potassium Chloride 20meq1.49GM/100ML · injectable;injection | Potassium Chloride | Rx |
| Aug 7, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 7, 2021 | Supplement 1Manufacturing | Approved | None posted |
| Sep 9, 2020 | Original application | Approved |
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
