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FDA NDA · NDA019515

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: HOSPIRA

APPLICATION
NDA019515
TYPE
NDA
ORIGINAL APPROVAL
1986-05-08
LATEST ACTION
2013-09-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 53MG/100ML, POTASSIUM CHLORIDE 100MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 100MG/100ML, SODIUM CHLORIDE 180MG/100ML, SODIUM LACTATE 280MG/100ML, SODIUM PHOSPHATE, MONOBASIC ANHYDROUS 16MG/100ML · INJECTABLE · INJECTION

Approval history

2013-09-05Manufacturing (CMC) · Supplement 33 · standardAP
2001-07-11Labeling · Supplement 16 · standardAP
2000-06-20Labeling · Supplement 14 · standardAP
1998-06-22Manufacturing (CMC) · Supplement 15 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 11 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 10 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 13 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 12 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 8 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 7 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 4 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 5 · standardAP
1989-09-13Manufacturing (CMC) · Supplement 1 · standardAP
1986-05-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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