Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 224MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 75MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Discontinued | 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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17648scs061ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/11/2019 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017648s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017648Orig1s071ltr.pdf | |
| 11/17/2016 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2015 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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/2005/017648s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017648s064ltr.pdf | |
| 11/26/2002 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/10/2003 | SUPPL-58 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17648slr058ltr.pdf |
| 11/24/1999 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-45 | 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. |
||
| 10/04/1985 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-36 | 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. |
||
| 03/16/1984 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/12/1982 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1981 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1981 | 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-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1980 | 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. |
||
| 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 |
|---|---|---|---|---|---|
| 01/11/2019 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017648s071lbl.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/2005/017648s064lbl.pdf |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
INJECTABLE;INJECTION; 150MG/100ML;450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017648 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212347 | FRESENIUS KABI USA |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
INJECTABLE;INJECTION; 150MG/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017648 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212347 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 150MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019708 | B BRAUN |
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
INJECTABLE;INJECTION; 300MG/100ML;900MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017648 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% | POTASSIUM CHLORIDE; SODIUM CHLORIDE | 300MG/100ML;900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 212347 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%
There are no Therapeutic Equivalents.