NDA 18563, held by Otsuka Icu Medcl. Dextrose.
As of Nov 13, 2026, NDA 18563 (Dextrose 50% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Mar 23, 1982, with 38 approved supplements and 0 published complete response letters.
Dextrose Injection 20%, 30%, 40%, 50% and 70%, mixed with amino acids or other compatible intravenous fluids, is indicated as a source of calories for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 1982 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dextrose 50% In Plastic Container50GM/100ML · injectable;injection | Dextrose | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2018 | Supplement 60Labeling · Standard review | Approved | |
| Feb 22, 2016 | Supplement 57Labeling · Standard review | Approved | |
| Sep 11, 2003 | Supplement 43Labeling | Approved | None posted |
| Nov 1, 2002 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Jul 16, 1999 | Supplement 40Labeling | Approved | None posted |
| May 27, 1999 | Supplement 38Labeling | Approved | None posted |
| Dec 1, 1998 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Aug 20, 1997 | Supplement 35Labeling | Approved | None posted |
| Jun 11, 1997 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1997 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1996 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Aug 6, 1996 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1996 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1995 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Dec 13, 1993 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1993 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1992 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Sep 10, 1991 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jan 11, 1990 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1988 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1986 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1986 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jun 25, 1986 | Supplement 5Labeling | Approved | None posted |
| Jun 25, 1986 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jan 31, 1986 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Oct 29, 1985 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1985 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1985 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 28, 1984 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1984 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1984 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 8, 1984 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1984 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 1, 1984 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Feb 17, 1984 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1984 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1982 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 23, 1982 | 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
