For minimal carbohydrate calories. NDA 18371, held by Otsuka Icu Medcl. Dextrose; Potassium Chloride.
As of Nov 13, 2026, NDA 18371 (Potassium Chloride 20meq In Dextrose 5% In Plastic Container, Potassium Chloride 40meq In Dextrose 5% In Plastic Container, Potassium Chloride 30meq In Dextrose 5% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on May 29, 1980, with 62 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE This solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Potassium Chloride 20meq In Dextrose 5% In Plastic Container5GM/100ML;149MG/100ML · injectable;injection | Dextrose; Potassium Chloride | Rx |
| Potassium Chloride 40meq In Dextrose 5% In Plastic Container5GM/100ML;298MG/100ML · injectable;injection | Dextrose; Potassium Chloride | Discontinued |
| Potassium Chloride 30meq In Dextrose 5% In Plastic Container5GM/100ML;224MG/100ML · injectable;injection | Dextrose; Potassium Chloride | Discontinued |
| Sep 8, 2014 | Supplement 91Manufacturing · Standard review | Approved | None posted |
| Jul 27, 2001 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1999 | Supplement 65Labeling | Approved | None posted |
| May 26, 1999 | Supplement 72Labeling | Approved | None posted |
| Feb 1, 1999 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1999 | Supplement 71Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1997 | Supplement 67Labeling | Approved | None posted |
| Jun 11, 1997 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1989 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| May 25, 1988 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| May 25, 1988 | Supplement 49Labeling | Approved | None posted |
| Nov 26, 1986 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 31Labeling | Approved | None posted |
| Nov 29, 1985 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 40Labeling | Approved | None posted |
| Sep 26, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1984 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 19Labeling | Approved | None posted |
| Oct 10, 1984 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jul 5, 1983 | Supplement 23Labeling | Approved | None posted |
| Jul 5, 1983 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1982 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1981 | Supplement 8Labeling | Approved | None posted |
| Jun 20, 1981 | Supplement 6Labeling | Approved | None posted |
| Apr 8, 1981 | Supplement 5Labeling | Approved | None posted |
| Apr 8, 1981 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 29, 1980 | Original applicationNew formulation or manufacturer · Standard review | 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
