ANDA 80225, held by Fresenius Kabi USA. Potassium Chloride.
As of Nov 15, 2026, ANDA 80225 (Potassium Chloride), held by Fresenius Kabi USA, was first approved by FDA on Jun 30, 1971, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 1971 | Original application | Approved | None posted |
| Potassium Chloride2MEQ/ML · injectable;injection | Potassium Chloride | DiscontinuedReference drug |
| Potassium Chloride3MEQ/ML · injectable;injection | Potassium Chloride | Discontinued |
| Dec 6, 1994 | Supplement 47Manufacturing | Approved | None posted |
| Dec 6, 1994 | Supplement 53Manufacturing | Approved | None posted |
| Jan 13, 1993 | Supplement 52Labeling | Approved | None posted |
| Nov 25, 1992 | Supplement 51Labeling | Approved | None posted |
| Apr 26, 1991 | Supplement 50Labeling | Approved | None posted |
| Dec 18, 1990 | Supplement 49Labeling | Approved | None posted |
| Jun 1, 1990 | Supplement 48Labeling | Approved | None posted |
| Oct 28, 1987 | Supplement 44Manufacturing | Approved | None posted |
| Oct 28, 1987 | Supplement 45Manufacturing | Approved | None posted |
| Nov 27, 1984 | Supplement 41Manufacturing | Approved | None posted |
| May 1, 1984 | Supplement 39Manufacturing | Approved | None posted |
| Feb 13, 1984 | Supplement 38Manufacturing | Approved | None posted |
| Nov 1, 1982 | Supplement 37Manufacturing | Approved | None posted |
| Jun 23, 1982 | Supplement 34Manufacturing | Approved | None posted |
| Jun 30, 1971 | 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
