Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019904
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 746MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2.24GM/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/26/1989 | 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 |
|---|---|---|---|---|---|
| 06/13/2022 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019904s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019904Orig1s021ltr.pdf | |
| 06/20/2019 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019904s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019904Orig1s020ltr.pdf | |
| 02/03/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/2017 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019904s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019904Orig1s014ltr.pdf | |
| 03/14/2012 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019904s012ltr.pdf |
| 12/31/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/17/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/17/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1991 | 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 |
|---|---|---|---|---|---|
| 06/13/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019904s021lbl.pdf | |
| 06/20/2019 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019904s020lbl.pdf | |
| 01/07/2017 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019904s014lbl.pdf |
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 14.9MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS |
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 14.9MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |
INJECTABLE;INJECTION; 746MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | 746MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 746MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 1.49GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 1.49GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |
INJECTABLE;INJECTION; 29.8MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 29.8MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 2.98GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 40MEQ | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 211087 | FRESENIUS KABI USA |
| POTASSIUM CHLORIDE 40MEQ | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 214727 | NEXUS |
| POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019904 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER | POTASSIUM CHLORIDE | 2.98GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020161 | ICU MEDICAL INC |