Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 20% IN PLASTIC CONTAINER | DEXTROSE | 20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DEXTROSE 30% IN PLASTIC CONTAINER | DEXTROSE | 30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DEXTROSE 40% IN PLASTIC CONTAINER | DEXTROSE | 40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DEXTROSE 50% IN PLASTIC CONTAINER | DEXTROSE | 50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DEXTROSE 60% IN PLASTIC CONTAINER | DEXTROSE | 60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DEXTROSE 70% IN PLASTIC CONTAINER | DEXTROSE | 70GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/28/1979 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/23/2016 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2016 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2018 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017521s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017521Orig1s069ltr.pdf | |
| 12/22/2014 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016673Orig1s147,016694Orig1s119,017521Orig1s068,020047Orig1s020ltr.pdf | |
| 08/14/2001 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/2002 | SUPPL-63 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf |
| 11/14/2002 | SUPPL-62 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17521slr062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017521_s062_s063_DEXTROSE_INJ.pdf |
| 12/07/2000 | SUPPL-61 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1999 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1998 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-57 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1993 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/1987 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/23/1985 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/1984 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1984 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1982 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/26/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/09/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1980 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/18/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/14/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017521s069lbl.pdf | |
| 12/22/2014 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf |