Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019904
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
06/20/2019 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
06/20/2019 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 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 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 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 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 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

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