Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021703
Company: BAXTER HLTHCARE CORP
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 |
---|---|---|---|---|---|
05/02/2023 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021703s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021703Orig1s023ltr.pdf | |
11/01/2018 | SUPPL-20 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf | |
10/10/2008 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |
---|---|---|---|---|---|
05/02/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021703s023lbl.pdf | |
11/01/2018 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021703Orig1s020, 207026Orig1s006lbl.pdf | |
11/01/2018 | SUPPL-20 | Labeling-Container/Carton Labels | 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf | |
04/20/2009 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021703s004lbl.pdf | |
10/10/2008 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021703s003lbl.pdf | |
10/10/2008 | SUPPL-3 | Labeling-Package Insert | 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 |