Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019367
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/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 |
|---|---|---|---|---|---|---|---|
| 04/05/1985 | 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 |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019367s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016682Orig1s117,%20019367Orig1s036,%20016679Orig1s114ltr.pdf | |
| 09/30/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2017 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019367s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019367s030ltr.pdf | |
| 04/26/2013 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/2011 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016679s104,016682s105,016692s095,019367s026ltr.pdf | |
| 08/26/2005 | SUPPL-22 | 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-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019367s021ltr.pdf | |
| 08/14/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2003 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19367slr015ltr.pdf |
| 11/24/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 10/09/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019367s036lbl.pdf | |
| 12/06/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019367s030lbl.pdf | |
| 10/19/2011 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016679s104,016682s105,016692s095,019367s026lbl.pdf | |
| 08/26/2005 | SUPPL-22 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf | |
| 06/07/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019367s021lbl.pdf |
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019685 | ICU MEDICAL INC |
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
| POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019367 | BAXTER HLTHCARE |
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.