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FDA ANDA · ANDA020374

INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

Sponsor: FRESENIUS

APPLICATION
ANDA020374
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-13
LATEST ACTION
2002-01-22
ROUTE
INTRAPERITONEAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 18.4MG/100ML, DEXTROSE 2.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 18.4MG/100ML, DEXTROSE 3.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 18.4MG/100ML, DEXTROSE 1.5GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 18.4MG/100ML, DEXTROSE 4.25GM/100ML, MAGNESIUM CHLORIDE 5.08MG/100ML, SODIUM CHLORIDE 538MG/100ML, SODIUM LACTATE 448MG/100ML · SOLUTION · INTRAPERITONEAL

Approval history

2002-01-22Manufacturing (CMC) · Supplement 6 · standardAP
2002-01-22Labeling · Supplement 7AP
2001-02-14Manufacturing (CMC) · Supplement 5 · standardAP
2000-01-10Manufacturing (CMC) · Supplement 8 · standardAP
1997-07-22Manufacturing (CMC) · Supplement 2 · standardAP
1996-04-29Manufacturing (CMC) · Supplement 4 · standardAP
1996-04-24Labeling · Supplement 3AP
1996-04-24Manufacturing (CMC) · Supplement 1 · standardAP
1994-06-13Type 5 - New Formulation or New Manufacturer · Original · standardAP
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