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FDA NDA · NDA018274

ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA018274
TYPE
NDA
ORIGINAL APPROVAL
1980-08-11
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 370MG/100ML, SODIUM CHLORIDE 530MG/100ML, SODIUM GLUCONATE 500MG/100ML · INJECTABLE · INJECTION

Approval history

1990-09-11Manufacturing (CMC) · Supplement 18AP
1987-12-29Labeling · Supplement 16AP
1987-11-05Manufacturing (CMC) · Supplement 11AP
1987-07-09Labeling · Supplement 15AP
1986-02-18Manufacturing (CMC) · Supplement 9AP
1986-02-14Labeling · Supplement 13AP
1985-06-28Manufacturing (CMC) · Supplement 10AP
1985-04-03Manufacturing (CMC) · Supplement 12AP
1984-12-10Manufacturing (CMC) · Supplement 6AP
1983-01-17Labeling · Supplement 8AP
1981-12-16Labeling · Supplement 5AP
1981-10-26Manufacturing (CMC) · Supplement 7AP
1980-12-12Manufacturing (CMC) · Supplement 3AP
1980-12-10Manufacturing (CMC) · Supplement 4AP
1980-11-24Manufacturing (CMC) · Supplement 2AP
1980-10-07Manufacturing (CMC) · Supplement 1AP
1980-08-11OriginalAP
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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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