Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE | 5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 02/02/1979 | 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 |
|---|---|---|---|---|---|
| 02/13/2020 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017484s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/017484Orig1s076ltr.pdf | |
| 07/11/2018 | SUPPL-74 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017385Orig1s064,017484Origs074,018629Orig1s048ltr.pdf | |
| 03/24/2016 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2015 | 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. |
||
| 04/26/2013 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/2005 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf | |
| 06/07/2005 | SUPPL-61 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017484s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017484s061ltr.pdf | |
| 08/14/2001 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/2000 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1991 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | 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-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1985 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1982 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1981 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/09/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/18/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1980 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1980 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1980 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1980 | 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 |
|---|---|---|---|---|---|
| 02/13/2020 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/017484s076lbl.pdf | |
| 08/26/2005 | SUPPL-62 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf | |
| 06/07/2005 | SUPPL-61 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017484s061lbl.pdf |