NDA 17385, held by Baxter Hlthcare. Dextrose; Magnesium Acetate Tetrahydrate; Potassium Acetate; Sodium Chloride.
As of Nov 13, 2026, NDA 17385 (Plasma-Lyte 56 And Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Feb 1, 1979, with 47 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Plasma-Lyte 56 And Dextrose 5% In Plastic Container5GM/100ML;32MG/100ML;128MG/100ML;234MG/100ML · injectable;injection | Dextrose; Magnesium Acetate Tetrahydrate; Potassium Acetate; Sodium Chloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2018 | Supplement 64 | Approved | |
| Mar 18, 2016 | Supplement 62Labeling · Standard review | Approved | |
| Dec 22, 2014 | Supplement 60Labeling · Standard review | Approved | |
| Sep 11, 2013 | Supplement 59Labeling · Standard review | Approved | |
| Aug 14, 2001 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Feb 1, 2001 | Supplement 51Labeling · Standard review | Approved | None posted |
| Nov 29, 2000 | Supplement 49Labeling · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1991 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1985 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Apr 18, 1985 | Supplement 34Labeling | Approved | None posted |
| Apr 15, 1985 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 23Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1982 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 18Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1980 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 10, 1979 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1979 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 1, 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
