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FDA NDA · NDA018273
ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: B BRAUN
APPLICATION
NDA018273
TYPE
NDA
ORIGINAL APPROVAL
1980-10-06
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 97MG/100ML, SODIUM ACETATE 220MG/100ML, SODIUM CHLORIDE 140MG/100ML · INJECTABLE · INJECTION
Approval history
1990-09-11Manufacturing (CMC) · Supplement 16 · standardAP
1987-12-28Labeling · Supplement 14 · standardAP
1987-07-09Labeling · Supplement 13 · 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
1980-12-30Manufacturing (CMC) · Supplement 4 · standardAP
1980-12-11Manufacturing (CMC) · Supplement 2 · standardAP
1980-12-03Manufacturing (CMC) · Supplement 3 · standardAP
1980-10-06Type 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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