NDA 17521, held by Baxter Hlthcare. Dextrose.
As of Nov 14, 2026, NDA 17521 (Dextrose 50% In Plastic Container, Dextrose 40% In Plastic Container, Dextrose 30% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Aug 28, 1979, with 54 approved supplements and 0 published complete response letters.
| Dec 7, 2000 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 28, 1979 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Dextrose 50% In Plastic Container50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dextrose | DiscontinuedReference drug |
| Dextrose 40% In Plastic Container40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dextrose | DiscontinuedReference drug |
| Dextrose 30% In Plastic Container30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dextrose | DiscontinuedReference drug |
| Dextrose 20% In Plastic Container20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dextrose | DiscontinuedReference drug |
| Dextrose 60% In Plastic Container60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dextrose | DiscontinuedReference drug |
| Dextrose 70% In Plastic Container70GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dextrose | DiscontinuedReference drug |
| Mar 14, 2018 | Supplement 69Labeling · Standard review | Approved | |
| Mar 23, 2016 | Supplement 72Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2016 | Supplement 71Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2015 | Supplement 70Manufacturing · Standard review | Approved | None posted |
| Dec 22, 2014 | Supplement 68Labeling · Standard review | Approved | |
| Nov 14, 2002 | Supplement 63Labeling · Standard review | Approved | |
| Nov 14, 2002 | Supplement 62Labeling · Standard review | Approved | |
| Aug 14, 2001 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2000 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 24, 1999 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| May 25, 1999 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Jun 22, 1998 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1997 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1995 | Supplement 50Labeling | Approved | None posted |
| Jan 5, 1995 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1994 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1994 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Jul 13, 1993 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1991 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1991 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| May 18, 1990 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1989 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Jan 12, 1989 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1987 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jun 13, 1985 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1985 | Supplement 38Labeling | Approved | None posted |
| Apr 15, 1985 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1985 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 22, 1984 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Sep 21, 1984 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Aug 24, 1984 | Supplement 33Labeling | Approved | None posted |
| Mar 16, 1984 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1984 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1982 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1982 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1982 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1982 | Supplement 15Labeling | Approved | None posted |
| Feb 16, 1982 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1981 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1981 | Supplement 17Labeling | Approved | None posted |
| Jun 29, 1981 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1981 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 21, 1981 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1980 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1980 | Supplement 10Labeling | Approved | None posted |
| Aug 6, 1980 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 31, 1980 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1980 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 18, 1980 | Supplement 2Labeling | Approved | None posted |
| Jun 18, 1980 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 30, 1980 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1980 | Supplement 5Manufacturing · 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
