ANDA 214395, held by Guangzhou Novaken. Potassium Chloride.
As of Nov 15, 2026, ANDA 214395 (Potassium Chloride), held by Guangzhou Novaken, was first approved by FDA on Jan 28, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2021 | Original application | Approved | None posted |
| Potassium Chloride10MEQ · tablet, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride20MEQ · tablet, extended release;oral | 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