NDA 17484, held by Baxter Hlthcare. Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Chloride; Sodium Lactate.
As of Nov 13, 2026, NDA 17484 (Dextrose 5% And Electrolyte No. 48 In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Feb 2, 1979, with 53 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% And Electrolyte No. 48 In Plastic Container5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML · injectable;injection | Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Chloride; Sodium Lactate | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2020 | Supplement 76Labeling · Standard review | Approved | |
| Jul 11, 2018 | Supplement 74 | Approved | |
| Mar 24, 2016 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Nov 13, 2015 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2015 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Apr 26, 2013 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Aug 26, 2005 | Supplement 62Manufacturing · Standard review | Approved | |
| Jun 7, 2005 | Supplement 61Labeling · Standard review | Approved | |
| Aug 14, 2001 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Nov 29, 2000 | Supplement 55Labeling · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1991 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1989 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1985 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Apr 17, 1985 | Supplement 37Labeling | Approved | None posted |
| Apr 15, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 23Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1982 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1981 | Supplement 14Labeling | Approved | None posted |
| Aug 26, 1981 | Supplement 21Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 11Manufacturing · 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 |
| Aug 6, 1980 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 1Manufacturing · Standard review | 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 | 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
