APPLICATION
NDA018725
TYPE
NDA
ORIGINAL APPROVAL
1982-11-29
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ACETATED RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 20MG/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM ACETATE 380MG/100ML, SODIUM CHLORIDE 600MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 6 · standardAP
1985-05-24Labeling · Supplement 4 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 2 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 3 · standardAP
1982-11-29Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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