APPLICATION
NDA018023
TYPE
NDA
ORIGINAL APPROVAL
1978-02-21
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LACTATED RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 20MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 23AP
1986-02-18Manufacturing (CMC) · Supplement 16AP
1985-08-02Labeling · Supplement 21AP
1985-05-17Manufacturing (CMC) · Supplement 17AP
1985-04-15Manufacturing (CMC) · Supplement 18AP
1985-04-03Manufacturing (CMC) · Supplement 19AP
1983-01-24Labeling · Supplement 14AP
1981-10-26Manufacturing (CMC) · Supplement 15AP
1980-10-24Manufacturing (CMC) · Supplement 12AP
1980-09-25Manufacturing (CMC) · Supplement 13AP
1980-08-06Manufacturing (CMC) · Supplement 11AP
1980-07-16Manufacturing (CMC) · Supplement 10AP
1980-02-12Manufacturing (CMC) · Supplement 9AP
1979-10-16Manufacturing (CMC) · Supplement 7AP
1979-10-09Labeling · Supplement 8AP
1979-06-08Manufacturing (CMC) · Supplement 6AP
1979-03-29Manufacturing (CMC) · Supplement 4AP
1979-03-29Labeling · Supplement 5AP
1978-09-29Labeling · Supplement 3AP
1978-09-26Manufacturing (CMC) · Supplement 2AP
1978-03-23Manufacturing (CMC) · Supplement 1AP
1978-02-21OriginalAP
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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