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 POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;75MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;224MG/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | No |
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/1979 | 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 |
|---|---|---|---|---|---|
| 07/15/2019 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017634s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017634Orig1s076ltr.pdf | |
| 05/26/2017 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017634Orig1s071s073ltr.pdf | |
| 05/26/2017 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017634Orig1s071s073ltr.pdf | |
| 09/25/2014 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2014 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017634s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017634Orig1s069ltr.pdf | |
| 08/26/2005 | SUPPL-65 | 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 | |
| 05/23/2005 | SUPPL-64 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017634s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017634s064ltr.pdf | |
| 08/14/2001 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2003 | SUPPL-59 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17634slr059ltr.pdf |
| 11/24/1999 | SUPPL-58 | Manufacturing (CMC) |
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. |
||
| 02/14/1992 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1984 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/12/1982 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 07/11/1983 | SUPPL-27 | Labeling |
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. |
||
| 11/09/1981 | SUPPL-23 | Manufacturing (CMC)-Control |
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. |
||
| 05/29/1981 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/18/1980 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1980 | SUPPL-8 | 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. |
||
| 05/28/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/02/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1980 | 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 |
|---|---|---|---|---|---|
| 07/15/2019 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017634s076lbl.pdf | |
| 05/26/2017 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf | |
| 05/26/2017 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017634s071s073lbl.pdf | |
| 12/22/2014 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017634s069lbl.pdf | |
| 08/26/2005 | SUPPL-65 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf | |
| 05/23/2005 | SUPPL-64 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017634s064lbl.pdf |
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;75MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;75MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212346 | FRESENIUS KABI USA |
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;75MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017634 | BAXTER HLTHCARE |
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;150MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212346 | FRESENIUS KABI USA |
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017634 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;150MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019699 | B BRAUN |
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML;300MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017634 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE | 5GM/100ML;300MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019699 | B BRAUN |