ANDA 207528, held by Sigmapharm Labs LLC. Potassium Chloride.
As of Nov 15, 2026, ANDA 207528 (Potassium Chloride), held by Sigmapharm Labs LLC, was first approved by FDA on Aug 19, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2016 | Original application | Approved | None posted |
| Potassium Chloride8MEQ · tablet, extended release;oral | Potassium Chloride | Discontinued |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Discontinued |
| Apr 27, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 19, 2016 | 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
