Prismasol Bk 0/3.5 In Plastic Container, Prismasol Bgk 2/0 In Plastic Container, Prismasol Bgk 2/3.5 In Plastic Container

NDA 21703, held by Vantive US Hlthcare. Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride.

As of Nov 15, 2026, NDA 21703 (Prismasol Bk 0/3.5 In Plastic Container, Prismasol Bgk 2/0 In Plastic Container, Prismasol Bgk 2/3.5 In Plastic Container), held by Vantive US Hlthcare, was first approved by FDA on Oct 25, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 25, 2006
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration and to correct electrolyte and acid-base imbalances. They may also be used in case of drug poisoning when CRRT is used to remove dialyzable substances. PRISMASOL and PHOXILLUM solutions are indicated:

As a replacement solution in Continuous Renal Replacement Therapy (CRRT) and in case of drug poisoning when CRRT is used to remove dialyzable substances

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 25, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

15 strengths and forms


Prismasol Bk 0/3.5 In Plastic Container5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	DiscontinuedReference drug
Prismasol Bgk 2/0 In Plastic ContainerN/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Prismasol Bgk 2/3.5 In Plastic Container5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Prismasol Bgk 4/2.5 In Plastic Container3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Prismasol Bgk 4/0 In Plastic ContainerN/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Discontinued
Prismasol Bgk 0/2.5 In Plastic Container3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Prismasol Bk 0/0 In Plastic ContainerN/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Discontinued
Prismasol Bgk 4/3.5 In Plastic Container5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Discontinued
Prismasol Bk 4/2.5 In Plastic Container3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Discontinued
Prismasol B22gk 2/0 In Plastic ContainerN/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	DiscontinuedReference drug
Prismasol B22gk 4/0 In Plastic ContainerN/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Prismasol B22gk 2/2.5 In Plastic Container3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	Discontinued
Prismasol B22gk 4/2.5 In Plastic Container3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	DiscontinuedReference drug
Prismasol Bk 0/0/1.2 In Plastic ContainerN/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Prismasol Bgk 4/0/1.2 In Plastic ContainerN/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML) · injectable;injection	Calcium Chloride; Dextrose; Lactic Acid; Magnesium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


May 2, 2023	Supplement 23Labeling · Standard review	Approved	Label Letter
Nov 1, 2018	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 30, 2017	Supplement 18Labeling · Standard review	Approved	Letter Label
Jul 20, 2016	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 10, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 15, 2015	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 17, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 13, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 18, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 10, 2013	Supplement 10Labeling · Standard review	Approved	Letter
Apr 13, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 20, 2009	Supplement 4Manufacturing	Approved	Label
Oct 10, 2008	Supplement 3Manufacturing	Approved	Label Letter
Oct 25, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21703
Drugs@FDA: Overview at FDA
Company: Vantive US Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters