ANDA 204828, held by Novel Labs Inc. Potassium Chloride.
As of Nov 15, 2026, ANDA 204828 (Potassium Chloride), held by Novel Labs Inc, was first approved by FDA on Aug 15, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2016 | Original application | Approved | None posted |
| Potassium Chloride8MEQ · capsule, extended release;oral | Potassium Chloride | Rx |
| Potassium Chloride10MEQ · capsule, 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
