← FDA DRUG APPROVALS

FDA NDA · NDA021703

PRISMASOL BGK2/0

magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride

Sponsor: VANTIVE US HLTHCARE

APPLICATION
NDA021703
TYPE
NDA
ORIGINAL APPROVAL
2006-10-25
LATEST ACTION
2023-05-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER · ReferenceDiscontinued
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.157GM/1000ML, SODIUM BICARBONATE 2.21GM/1000ML, SODIUM CHLORIDE 7.07GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 2.03GM/1000ML, POTASSIUM CHLORIDE 0.157GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 3.68GM/1000ML, DEXTROSE N/A/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 2.44GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BK 0/0 IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE N/A/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE N/A/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER · ReferenceDiscontinued
CALCIUM CHLORIDE 3.68GM/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 2.21GM/1000ML, SODIUM CHLORIDE 7.07GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 4/0 IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 2.21GM/1000ML, SODIUM CHLORIDE 7.07GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 5.15GM/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 2.03GM/1000ML, POTASSIUM CHLORIDE 0.157GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER · ReferenceDiscontinued
CALCIUM CHLORIDE 5.15GM/1000ML, DEXTROSE N/A/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 2.03GM/1000ML, POTASSIUM CHLORIDE N/A/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 5.15GM/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 2.03GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE N/A/1000ML, DEXTROSE N/A/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 2.44GM/1000ML, POTASSIUM CHLORIDE N/A/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 3.68GM/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE N/A/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 3.68GM/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.157GM/1000ML, SODIUM BICARBONATE 2.21GM/1000ML, SODIUM CHLORIDE 7.07GM/1000ML (5000ML) · INJECTABLE · INJECTION
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 3.68GM/1000ML, DEXTROSE 20GM/1000ML, LACTIC ACID 5.4GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.46GM/1000ML (5000ML) · INJECTABLE · INJECTION

Approval history

2023-05-02Labeling · Supplement 23 · standard — Label ↗AP
2018-11-01Labeling · Supplement 20 · standard — Label ↗AP
2017-06-30Labeling · Supplement 18 · standard — Label ↗AP
2016-07-20Labeling · Supplement 17 · standard — Label ↗AP
2016-02-10Manufacturing (CMC) · Supplement 14 · standardAP
2015-12-15Labeling · Supplement 16 · standard — Letter ↗AP
2015-06-17Manufacturing (CMC) · Supplement 13 · standardAP
2013-12-13Manufacturing (CMC) · Supplement 12 · standardAP
2013-10-18Manufacturing (CMC) · Supplement 11 · standardAP
2013-06-10Labeling · Supplement 10 · standard — Letter ↗AP
2012-04-13Labeling · Supplement 8 · standard — Letter ↗AP
2009-04-20Manufacturing (CMC) · Supplement 4 — Label ↗AP
2008-10-10Manufacturing (CMC) · Supplement 3 — Label ↗AP
2006-10-25Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →