NDA 19561, held by Kv Pharm. Potassium Chloride.
As of Nov 13, 2026, NDA 19561 (Micro-K Ls), held by Kv Pharm, was first approved by FDA on Aug 26, 1988, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 1988 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Micro-K Ls20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for suspension, extended release;oral | Potassium Chloride | DiscontinuedReference drug |
| Aug 22, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Jan 13, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1988 | Original applicationNew dosage form · Standard review | 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
