NDA 17648, held by Baxter Hlthcare. Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 17648 (Potassium Chloride 0.15% In Sodium Chloride 0.9%, Potassium Chloride 0.3% And Sodium Chloride 0.9%, Potassium Chloride 0.224% In Sodium Chloride 0.9%), held by Baxter Hlthcare, was first approved by FDA on Feb 2, 1979, with 52 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Chloride 0.15% In Sodium Chloride 0.9%150MG/100ML;900MG/100ML · injectable;injection | Potassium Chloride; Sodium Chloride | RxReference drug |
| Potassium Chloride 0.3% And Sodium Chloride 0.9%300MG/100ML;900MG/100ML · injectable;injection | Potassium Chloride; Sodium Chloride | RxReference drug |
| Potassium Chloride 0.224% In Sodium Chloride 0.9%224MG/100ML;900MG/100ML · injectable;injection | Potassium Chloride; Sodium Chloride | DiscontinuedReference drug |
| Sodium Chloride 0.9% And Potassium Chloride 0.075%75MG/100ML;900MG/100ML · injectable;injection | Potassium Chloride; Sodium Chloride | Discontinued |
| Potassium Chloride 0.15% In Sodium Chloride 0.45%150MG/100ML;450MG/100ML · injectable;injection | Potassium Chloride; Sodium Chloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2019 | Supplement 71Labeling · Standard review | Approved | |
| Nov 17, 2016 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Jan 12, 2015 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Aug 26, 2005 | Supplement 65Manufacturing · Standard review | Approved | |
| May 23, 2005 | Supplement 64Labeling · Standard review | Approved | |
| Jan 10, 2003 | Supplement 58Labeling · Standard review | Approved | |
| Nov 26, 2002 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Aug 14, 2001 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Dec 11, 1991 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1989 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 4, 1985 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1985 | Supplement 40Labeling | Approved | None posted |
| Jun 13, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1985 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 25, 1982 | Supplement 31Labeling | Approved | None posted |
| Apr 16, 1982 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Apr 12, 1982 | Supplement 30Labeling | Approved | None posted |
| Dec 21, 1981 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 22Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 29, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 28, 1980 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1980 | Supplement 12Labeling | Approved | None posted |
| Aug 2, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1979 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1979 | Original applicationNew formulation or manufacturer · 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
