Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017648
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% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription AP Yes Yes
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
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% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription AP Yes No
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER 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 Letter (PDF)

Label is not available on this site.

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
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% IN PLASTIC CONTAINER

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% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;450MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription No AP 019708 B BRAUN
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 150MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE

POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%

There are no Therapeutic Equivalents.

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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% IN PLASTIC CONTAINER POTASSIUM CHLORIDE; SODIUM CHLORIDE 300MG/100ML;900MG/100ML INJECTABLE;INJECTION Prescription Yes AP 017648 BAXTER HLTHCARE

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

There are no Therapeutic Equivalents.

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