NDA 16697, held by Baxter Hlthcare. Dextrose; Sodium Chloride.
As of Nov 13, 2026, NDA 16697 (Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Mar 22, 1971, with 70 approved supplements and 0 published complete response letters.
Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 1971 | 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 | RxReference drug |
| Aug 22, 2019 | Supplement 98Labeling · Standard review | Approved | |
| Aug 29, 2014 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2013 | Supplement 96Labeling · Standard review | Approved | |
| Jun 2, 2004 | Supplement 91Labeling · Standard review | Approved | None posted |
| Aug 14, 2001 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Nov 29, 2000 | Supplement 87Labeling · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 85Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1991 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1991 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1989 | Supplement 77Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1987 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| May 28, 1987 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Feb 27, 1986 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1985 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Jul 3, 1985 | Supplement 71Labeling | Approved | None posted |
| Jun 13, 1985 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Apr 15, 1985 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1984 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1983 | Supplement 59Labeling | Approved | None posted |
| Jun 3, 1982 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1982 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 53Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1980 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1980 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jun 28, 1980 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 25, 1980 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1979 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1978 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1978 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1978 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Aug 2, 1978 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Jun 20, 1978 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Apr 25, 1978 | Supplement 33Labeling | Approved | None posted |
| Mar 24, 1978 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1978 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Dec 14, 1977 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1977 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Feb 7, 1977 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1976 | Supplement 18Labeling | Approved | None posted |
| Jul 13, 1976 | Supplement 24Labeling | Approved | None posted |
| Jul 1, 1976 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 17, 1976 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 11, 1976 | Supplement 16Labeling | Approved | None posted |
| Jan 5, 1976 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 2, 1976 | Supplement 21Labeling | Approved | None posted |
| Sep 23, 1975 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1975 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 10, 1975 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1975 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1971 | 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
