ANDA 87584, held by Luitpold. Potassium Chloride.
As of Nov 15, 2026, ANDA 87584 (Potassium Chloride), held by Luitpold, was first approved by FDA on Jun 30, 1981, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride2MEQ/ML ยท injectable;injection | Potassium Chloride | Discontinued |
| Nov 7, 1997 | Supplement 19Manufacturing | Approved | None posted |
| Mar 6, 1996 | Supplement 18Manufacturing | Approved | None posted |
| Feb 28, 1996 | Supplement 17Manufacturing | Approved | None posted |
| Nov 22, 1991 | Supplement 16Labeling | Approved | None posted |
| Aug 2, 1991 | Supplement 13Manufacturing | Approved | None posted |
| Jul 29, 1991 | Supplement 14Manufacturing | Approved | None posted |
| May 6, 1991 | Supplement 15Labeling | Approved | None posted |
| Mar 27, 1991 | Supplement 11Manufacturing | Approved | None posted |
| Mar 12, 1991 | Supplement 10Labeling | Approved | None posted |
| Jul 11, 1989 | Supplement 12Manufacturing | Approved | None posted |
| Jan 13, 1986 | Supplement 8Manufacturing | Approved | None posted |
| Jan 13, 1986 | Supplement 7Manufacturing | Approved | None posted |
| Jan 13, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Sep 23, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Sep 17, 1982 | Supplement 2Manufacturing | Approved | None posted |
| Jun 30, 1981 | 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
