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FDA NDA · NDA019395
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
Sponsor: FRESENIUS MEDCL
APPLICATION
NDA019395
TYPE
NDA
ORIGINAL APPROVAL
1986-03-26
LATEST ACTION
1999-09-27
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 4.25GM/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
Approval history
1999-09-27Manufacturing (CMC) · Supplement 12 · standardAP
1996-07-03Manufacturing (CMC) · Supplement 11 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 9 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 8 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 5 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 6 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 2 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 1 · standardAP
1986-03-26Type 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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