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FDA NDA · NDA018883
DELFLEX
dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Sponsor: FRESENIUS MEDCL
APPLICATION
NDA018883
TYPE
NDA
ORIGINAL APPROVAL
1984-11-30
LATEST ACTION
2021-01-26
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL
Approval history
2016-07-18Manufacturing (CMC) · Supplement 61 · standardAP
2015-12-28Manufacturing (CMC) · Supplement 58 · standardAP
2014-12-08Manufacturing (CMC) · Supplement 56 · standardAP
2014-08-07Manufacturing (CMC) · Supplement 55 · standardAP
2014-04-23Manufacturing (CMC) · Supplement 54 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 53 · standardAP
2014-01-13Manufacturing (CMC) · Supplement 52 · standardAP
2013-08-15Manufacturing (CMC) · Supplement 49 · standardAP
2013-07-26Manufacturing (CMC) · Supplement 50 · standardAP
2013-02-22Manufacturing (CMC) · Supplement 47 · standardAP
2008-05-06Manufacturing (CMC) · Supplement 32AP
2001-09-26Manufacturing (CMC) · Supplement 26 · standardAP
1999-05-18Manufacturing (CMC) · Supplement 25 · standardAP
1997-02-24Manufacturing (CMC) · Supplement 24 · standardAP
1996-06-14Manufacturing (CMC) · Supplement 23 · standardAP
1996-02-22Manufacturing (CMC) · Supplement 22 · standardAP
1996-01-19Manufacturing (CMC) · Supplement 21 · standardAP
1993-07-07Manufacturing (CMC) · Supplement 20 · standardAP
1993-07-07Labeling · Supplement 19AP
1993-07-07Manufacturing (CMC) · Supplement 18 · standardAP
1990-07-11Manufacturing (CMC) · Supplement 16 · standardAP
1990-01-24Manufacturing (CMC) · Supplement 9 · standardAP
1990-01-24Labeling · Supplement 12AP
1990-01-24Labeling · Supplement 10AP
1990-01-24Manufacturing (CMC) · Supplement 11 · standardAP
1989-01-10Manufacturing (CMC) · Supplement 15 · standardAP
1988-02-05Manufacturing (CMC) · Supplement 13 · standardAP
1987-10-27Labeling · Supplement 5AP
1987-10-27Manufacturing (CMC) · Supplement 4 · standardAP
1987-07-21Manufacturing (CMC) · Supplement 6 · standardAP
1987-04-08Manufacturing (CMC) · Supplement 8 · standardAP
1987-01-14Labeling · Supplement 7AP
1986-06-16Labeling · Supplement 3AP
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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