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FDA NDA · NDA019025

ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA019025
TYPE
NDA
ORIGINAL APPROVAL
1984-12-27
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 31MG/100ML, POTASSIUM CHLORIDE 130MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 26MG/100ML, SODIUM ACETATE 320MG/100ML · INJECTABLE · INJECTION

Approval history

1990-09-11Manufacturing (CMC) · Supplement 5 · standardAP
1987-12-29Labeling · Supplement 3 · standardAP
1987-07-09Labeling · Supplement 2 · standardAP
1985-09-18Manufacturing (CMC) · Supplement 1 · standardAP
1984-12-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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