← FDA DRUG APPROVALS

FDA NDA · NDA018608

PLEGISOL

potassium chloride, sodium chloride, calcium chloride, and magnesium chloride

Sponsor: HOSPIRA

APPLICATION
NDA018608
TYPE
NDA
ORIGINAL APPROVAL
1982-02-26
LATEST ACTION
2002-12-16
ROUTE
INTRA-ARTERIAL, PERFUSION, CARDIAC
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PLEGISOL IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 17.6MG/100ML, MAGNESIUM CHLORIDE 325.3MG/100ML, POTASSIUM CHLORIDE 119.3MG/100ML, SODIUM CHLORIDE 643MG/100ML · SOLUTION · PERFUSION, CARDIAC

Approval history

2002-12-16Labeling · Supplement 31 · standard — Letter ↗AP
2000-12-12Manufacturing (CMC) · Supplement 35 · priorityAP
1999-10-18Labeling · Supplement 34 · standardAP
1997-11-14Manufacturing (CMC) · Supplement 33 · priorityAP
1997-09-05Manufacturing (CMC) · Supplement 32 · priorityAP
1997-03-20Manufacturing (CMC) · Supplement 30 · priorityAP
1997-03-20Manufacturing (CMC) · Supplement 29 · priorityAP
1992-01-28Manufacturing (CMC) · Supplement 26 · priorityAP
1991-09-10Manufacturing (CMC) · Supplement 25 · priorityAP
1990-02-22Manufacturing (CMC) · Supplement 22 · priorityAP
1990-01-11Manufacturing (CMC) · Supplement 23 · priorityAP
1989-09-13Manufacturing (CMC) · Supplement 9 · priorityAP
1987-03-09Labeling · Supplement 10AP
1987-03-09Manufacturing (CMC) · Supplement 5 · priorityAP
1986-11-26Manufacturing (CMC) · Supplement 19 · priorityAP
1986-08-08Manufacturing (CMC) · Supplement 18 · priorityAP
1986-01-31Manufacturing (CMC) · Supplement 16 · priorityAP
1986-01-31Manufacturing (CMC) · Supplement 17 · priorityAP
1985-10-29Manufacturing (CMC) · Supplement 11 · priorityAP
1985-09-26Manufacturing (CMC) · Supplement 13 · priorityAP
1984-11-09Manufacturing (CMC) · Supplement 15 · priorityAP
1984-10-22Manufacturing (CMC) · Supplement 14 · priorityAP
1984-10-17Manufacturing (CMC) · Supplement 8 · priorityAP
1984-03-21Manufacturing (CMC) · Supplement 7 · priorityAP
1984-03-01Manufacturing (CMC) · Supplement 3 · priorityAP
1982-10-21Labeling · Supplement 1AP
1982-07-26Manufacturing (CMC) · Supplement 4 · priorityAP
1982-06-18Manufacturing (CMC) · Supplement 2 · priorityAP
1982-02-26Type 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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