Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021703
Company: BAXTER HLTHCARE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None Yes No
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None No No
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None Yes No
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None No No
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None No No
PRISMASOL BK 0/0 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None No No
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Prescription None Yes Yes
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) INJECTABLE;INJECTION Discontinued None Yes No
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) 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
10/25/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021703lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021703s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021703s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2018 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021703Orig1s020, 207026Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021703Orig1s020,207026Orig1s006ltr.pdf
06/30/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021703s018,207026s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/21703Orig1s018,207026Orig1s004ltr.pdf
07/20/2016 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021703Orig1s017,207026Orig1s002ltr.pdf
12/15/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021703s016-207026s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021703Orig1s016,207026Orig1s001ltr.pdf
02/10/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/17/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/13/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/18/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/10/2013 SUPPL-10 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021703Orig1s010ltr.pdf
04/13/2012 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021703s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021703s008ltr.pdf
04/20/2009 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf
10/10/2008 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021703s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021703s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2018 SUPPL-20 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021703Orig1s020, 207026Orig1s006lbl.pdf
11/01/2018 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021703Orig1s020, 207026Orig1s006lbl.pdf
06/30/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021703s018,207026s004lbl.pdf
07/20/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021703s017,207026s002lbl.pdf
12/15/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021703s016-207026s001lbl.pdf
04/13/2012 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021703s008lbl.pdf
04/20/2009 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf
04/20/2009 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf
10/10/2008 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021703s003lbl.pdf
10/10/2008 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021703s003lbl.pdf
10/25/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021703lbl.pdf

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