ANDA 211067, held by Apotex. Potassium Chloride.
As of Nov 15, 2026, ANDA 211067 (Potassium Chloride), held by Apotex, was first approved by FDA on Aug 8, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2018 | Original application | Approved |
| Potassium Chloride20MEQ/15ML · solution;oral | Potassium Chloride | Discontinued |
| Potassium Chloride40MEQ/15ML · solution;oral | Potassium Chloride | Discontinued |
| Mar 31, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 30, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 8, 2018 | 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
