APPLICATION
NDA018256
TYPE
NDA
ORIGINAL APPROVAL
1979-08-28
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 860MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 13AP
1986-02-18Manufacturing (CMC) · Supplement 8AP
1985-06-28Manufacturing (CMC) · Supplement 9AP
1985-06-24Labeling · Supplement 11AP
1985-04-03Manufacturing (CMC) · Supplement 10AP
1983-01-24Labeling · Supplement 6AP
1981-10-26Manufacturing (CMC) · Supplement 7AP
1980-10-24Manufacturing (CMC) · Supplement 5AP
1980-08-06Manufacturing (CMC) · Supplement 4AP
1980-03-17Manufacturing (CMC) · Supplement 2AP
1980-02-19Labeling · Supplement 1AP
1980-02-12Manufacturing (CMC) · Supplement 3AP
1979-08-28OriginalAP
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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