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FDA NDA · NDA020577

ELLIOTTS B

sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate

Sponsor: LUKARE MEDICAL LLC

APPLICATION
NDA020577
TYPE
NDA
ORIGINAL APPROVAL
1996-09-27
LATEST ACTION
2016-11-29
ROUTE
INTRATHECAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ELLIOTTS B SOLUTION · ReferencePrescription
CALCIUM CHLORIDE 0.2MG/ML, DEXTROSE 0.8MG/ML, MAGNESIUM SULFATE 0.3MG/ML, POTASSIUM CHLORIDE 0.3MG/ML, SODIUM BICARBONATE 1.9MG/ML, SODIUM CHLORIDE 7.3MG/ML, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 0.2MG/ML · INJECTABLE · INTRATHECAL

Approval history

2016-11-29Manufacturing (CMC) · Supplement 10 · standardAP
2015-12-17Manufacturing (CMC) · Supplement 9 · priorityAP
2015-06-11Manufacturing (CMC) · Supplement 6 · priorityAP
2014-07-18Manufacturing (CMC) · Supplement 8 · priorityAP
2012-12-14Manufacturing (CMC) · Supplement 7 · priorityAP
2000-11-17Manufacturing (CMC) · Supplement 4 · priorityAP
1998-05-22Manufacturing (CMC) · Supplement 2 · priorityAP
1998-05-22Manufacturing (CMC) · Supplement 3 · priorityAP
1997-12-02Manufacturing (CMC) · Supplement 1 · priorityAP
1996-09-27Type 3 - New Dosage Form · Original · priorityAP
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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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