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FDA NDA · NDA018270

ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA018270
TYPE
NDA
ORIGINAL APPROVAL
1980-10-03
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 130MG/100ML, SODIUM ACETATE 280MG/100ML, SODIUM CHLORIDE 91MG/100ML · INJECTABLE · INJECTION

Approval history

1990-09-11Manufacturing (CMC) · Supplement 18 · standardAP
1988-04-22Labeling · Supplement 16 · standardAP
1987-12-31Labeling · Supplement 15 · standardAP
1986-06-10Manufacturing (CMC) · Supplement 13 · standardAP
1986-06-10Labeling · Supplement 14 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 9 · standardAP
1985-11-25Labeling · Supplement 12 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 10 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 11 · standardAP
1984-12-10Manufacturing (CMC) · Supplement 6 · standardAP
1983-01-17Labeling · Supplement 8 · standardAP
1981-12-16Labeling · Supplement 5 · standardAP
1981-10-26Manufacturing (CMC) · Supplement 7 · standardAP
1981-01-02Manufacturing (CMC) · Supplement 1 · standardAP
1980-12-30Manufacturing (CMC) · Supplement 4 · standardAP
1980-12-11Manufacturing (CMC) · Supplement 2 · standardAP
1980-12-10Manufacturing (CMC) · Supplement 3 · standardAP
1980-10-03Type 5 - New Formulation or New Manufacturer · Original · standardAP
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