NDA 18254, held by Hospira. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride.
As of Nov 13, 2026, NDA 18254 (Dextrose 5% And Ringer'S In Plastic Container), held by Hospira, was first approved by FDA on Jan 15, 1980, with 58 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 5% And Ringer'S In Plastic Container33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML · injectable;injection | Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride | Discontinued |
| Oct 28, 1999 | Supplement 68Labeling | Approved | None posted |
| Oct 12, 1999 | Supplement 65Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1989 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 32Labeling | Approved | None posted |
| Nov 29, 1985 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 41Labeling | Approved | None posted |
| Oct 26, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1984 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 21Labeling | Approved | None posted |
| Oct 10, 1984 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1983 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1982 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1982 | Supplement 10Labeling | Approved | None posted |
| Jun 9, 1982 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1981 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1981 | Supplement 11Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 8Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 20, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 20, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 15, 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
