NDA 18096, held by Hospira. Dextrose; Sodium Chloride.
As of Nov 13, 2026, NDA 18096 (Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container), held by Hospira, was first approved by FDA on Aug 17, 1979, with 64 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 17, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container2.5GM/100ML;450MG/100ML · injectable;injection | Dextrose; Sodium Chloride | Discontinued |
| Jul 18, 2002 | Supplement 74Labeling · Standard review | Approved | None posted |
| Mar 31, 1999 | Supplement 73Labeling · Standard review | Approved | None posted |
| Dec 1, 1998 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 70Labeling · Standard review | Approved | None posted |
| Jun 11, 1997 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 61Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1987 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 38Labeling · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 46Labeling · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 27Labeling · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1983 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1983 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1983 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1982 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 9, 1982 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 1, 1982 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1981 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 17Labeling · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 15Labeling · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1981 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 11, 1980 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1980 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 5, 1980 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 12, 1980 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1979 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1979 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 2, 1979 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1979 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 17, 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
