APPLICATION
NDA019006
TYPE
NDA
ORIGINAL APPROVAL
1984-04-02
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOLYTE S PH 7.4 IN PLASTIC CONTAINERDiscontinued
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, POTASSIUM PHOSPHATE, MONOBASIC 0.82MG/100ML, SODIUM ACETATE 370MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM GLUCONATE 500MG/100ML, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 12MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 4 · standardAP
1985-09-18Manufacturing (CMC) · Supplement 1 · standardAP
1984-04-02Type 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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