NDA 18080, held by Otsuka Icu Medcl. Dextrose.
As of Nov 13, 2026, NDA 18080 (Dextrose 10% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Aug 28, 1979, with 75 approved supplements and 0 published complete response letters.
Dextrose Injection (5% and 10%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 10% In Plastic Container10GM/100ML · injectable;injection | Dextrose | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2025 | Supplement 122Labeling · Standard review | Approved | |
| Sep 8, 2014 | Supplement 115Manufacturing · Standard review | Approved | None posted |
| Aug 7, 2008 | Supplement 99Labeling | Approved | None posted |
| Apr 24, 2003 | Supplement 84Labeling | Approved | None posted |
| Nov 1, 2002 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Jul 24, 2002 | Supplement 81Labeling | Approved | None posted |
| Mar 31, 1999 | Supplement 80Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 79Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 77Labeling | Approved | None posted |
| Jun 11, 1997 | Supplement 78Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 76Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1996 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 73Manufacturing · Standard review | Approved | None posted |
| Aug 14, 1995 | Supplement 69Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1993 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1993 | Supplement 61Labeling | Approved | None posted |
| Jan 28, 1992 | Supplement 65Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Aug 30, 1991 | Supplement 66Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1989 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1986 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1986 | Supplement 31Labeling | Approved | None posted |
| Jan 31, 1986 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1985 | Supplement 40Labeling | Approved | None posted |
| Oct 29, 1985 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1985 | Supplement 50Labeling | Approved | None posted |
| Sep 26, 1985 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1985 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| May 3, 1985 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1985 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Oct 10, 1984 | Supplement 27Labeling | Approved | None posted |
| Sep 8, 1984 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Apr 9, 1984 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1984 | Supplement 34Manufacturing · 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 |
| Feb 15, 1983 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1982 | Supplement 16Labeling | 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 |
| Oct 5, 1981 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1981 | Supplement 15Labeling | Approved | None posted |
| Jul 8, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 2, 1981 | Supplement 13Labeling | Approved | None posted |
| Mar 2, 1981 | Supplement 17Labeling | Approved | None posted |
| Jan 7, 1981 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 11, 1980 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 11, 1980 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 23, 1980 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 5, 1980 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Apr 8, 1980 | Supplement 4Labeling | Approved | None posted |
| Dec 7, 1979 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1979 | Supplement 2Labeling | Approved | None posted |
| Oct 10, 1979 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 28, 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
