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FDA NDA · NDA207026

PHOXILLUM BK4/2.5

calcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride, and sodium phosphate dibasic dihydrate

Sponsor: VANTIVE US HLTHCARE

APPLICATION
NDA207026
TYPE
NDA
ORIGINAL APPROVAL
2015-01-13
LATEST ACTION
2023-05-02
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 3.68GM/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML , SODIUM BICARBONATE 3.09GM/1000ML, SODIUM CHLORIDE 6.34GM/1000ML, SODIUM PHOSPHATE 0.187GM/1000ML (5000ML) · INJECTABLE · INJECTION
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE N/A/1000ML, MAGNESIUM CHLORIDE 3.05GM/1000ML, POTASSIUM CHLORIDE 0.314GM/1000ML, SODIUM BICARBONATE 2.21GM/1000ML, SODIUM CHLORIDE 6.95GM/1000ML, SODIUM PHOSPHATE 0.187GM/1000ML (5000ML) · INJECTABLE · INJECTION

Approval history

2023-05-02Labeling · Supplement 8 · standard — Label ↗AP
2018-11-01Labeling · Supplement 6 · standard — Label ↗AP
2017-06-30Labeling · Supplement 4 · standard — Label ↗AP
2016-07-20Labeling · Supplement 2 · standard — Label ↗AP
2015-12-15Labeling · Supplement 1 · standard — Letter ↗AP
2015-01-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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