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FDA NDA · NDA020171

DELFLEX

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Sponsor: FRESENIUS MEDCL

APPLICATION
NDA020171
TYPE
NDA
ORIGINAL APPROVAL
1992-08-19
LATEST ACTION
2021-01-26
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.4MG/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 LOW CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.4MG/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% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER · ReferencePrescription
CALCIUM CHLORIDE 18.4MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL

Approval history

2021-01-26Labeling · Supplement 80 · standard — Letter ↗AP
2016-03-24Manufacturing (CMC) · Supplement 41 · standardAP
2015-01-08Labeling · Supplement 39 · standard — Label ↗AP
2014-04-24Labeling · Supplement 33 · standard — Letter ↗AP
2014-04-23Manufacturing (CMC) · Supplement 36 · standardAP
2014-01-24Manufacturing (CMC) · Supplement 35 · standardAP
2014-01-13Manufacturing (CMC) · Supplement 34 · standardAP
2013-04-18Manufacturing (CMC) · Supplement 30 · standard — Label ↗AP
2013-02-22Manufacturing (CMC) · Supplement 29 · standardAP
2013-01-30Labeling · Supplement 26 · unknown — Label ↗AP
2009-09-14Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2008-05-06Manufacturing (CMC) · Supplement 14AP
2003-11-26Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2001-09-26Manufacturing (CMC) · Supplement 8 · standardAP
1999-05-18Manufacturing (CMC) · Supplement 7 · standardAP
1997-02-24Manufacturing (CMC) · Supplement 6 · standardAP
1996-06-14Manufacturing (CMC) · Supplement 5 · standardAP
1996-03-08Manufacturing (CMC) · Supplement 2 · standardAP
1996-02-22Manufacturing (CMC) · Supplement 4 · standardAP
1996-01-19Manufacturing (CMC) · Supplement 3 · standardAP
1994-03-10Manufacturing (CMC) · Supplement 1 · standardAP
1992-08-19Type 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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