FDA NDA · NDA018379

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

Sponsor: FRESENIUS MEDCL

APPLICATION

NDA018379

TYPE

NDA

ORIGINAL APPROVAL

1980-09-03

LATEST ACTION

2001-11-09

ROUTE

INTRAPERITONEAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINERDiscontinued

CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 3.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL

DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued

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 2.5% IN PLASTIC CONTAINERDiscontinued

CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued

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-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERDiscontinued

CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 3.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL

DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued

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-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued

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 1.5% IN PLASTIC CONTAINERDiscontinued

CALCIUM CHLORIDE 25.7MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 15.2MG/100ML, SODIUM CHLORIDE 567MG/100ML, SODIUM LACTATE 392MG/100ML · SOLUTION · INTRAPERITONEAL

Approval history

2001-11-09Manufacturing (CMC) · Supplement 95 · standardAP

1999-09-27Manufacturing (CMC) · Supplement 96 · standardAP

1997-08-14Manufacturing (CMC) · Supplement 94 · standardAP

1996-11-01Manufacturing (CMC) · Supplement 92 · standardAP

1996-07-03Manufacturing (CMC) · Supplement 93 · standardAP

1996-02-07Manufacturing (CMC) · Supplement 91 · standardAP

1996-01-23Manufacturing (CMC) · Supplement 89 · standardAP

1992-01-28Manufacturing (CMC) · Supplement 84 · standardAP

1991-09-10Manufacturing (CMC) · Supplement 83 · standardAP

1991-08-30Manufacturing (CMC) · Supplement 85 · standardAP

1990-08-01Manufacturing (CMC) · Supplement 80 · standardAP

1990-02-22Manufacturing (CMC) · Supplement 79 · standardAP

1990-01-11Manufacturing (CMC) · Supplement 81 · standardAP

1989-06-22Manufacturing (CMC) · Supplement 32 · standardAP

1989-06-14Manufacturing (CMC) · Supplement 78 · standardAP

1988-06-24Manufacturing (CMC) · Supplement 73 · standardAP

1988-06-24Manufacturing (CMC) · Supplement 71 · standardAP

1988-06-24Labeling · Supplement 74AP

1988-06-24Labeling · Supplement 72AP

1988-02-24Manufacturing (CMC) · Supplement 77 · standardAP

1988-02-02Manufacturing (CMC) · Supplement 76 · standardAP

1987-07-30Manufacturing (CMC) · Supplement 69 · standardAP

1987-04-28Manufacturing (CMC) · Supplement 63 · standardAP

1987-04-28Labeling · Supplement 64AP

1987-02-27Manufacturing (CMC) · Supplement 61 · standardAP

1987-02-27Labeling · Supplement 62AP

1987-02-11Manufacturing (CMC) · Supplement 65 · standardAP

1987-02-11Manufacturing (CMC) · Supplement 66 · standardAP

1986-11-26Manufacturing (CMC) · Supplement 68 · standardAP

1986-08-08Manufacturing (CMC) · Supplement 67 · standardAP

1986-02-26Manufacturing (CMC) · Supplement 57 · standardAP

1986-02-26Manufacturing (CMC) · Supplement 58 · standardAP

1986-02-21Manufacturing (CMC) · Supplement 60 · standardAP

1986-01-31Manufacturing (CMC) · Supplement 52 · standardAP

1986-01-18Manufacturing (CMC) · Supplement 55 · standardAP

1986-01-18Manufacturing (CMC) · Supplement 53 · standardAP

1986-01-18Labeling · Supplement 56AP

1986-01-18Labeling · Supplement 54AP

1985-12-10Manufacturing (CMC) · Supplement 41 · standardAP

1985-12-10Labeling · Supplement 42AP

VIEW ON DRUGS@FDA ↗

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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DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER

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