← FDA DRUG APPROVALS

FDA NDA · NDA019513

IONOSOL MB AND DEXTROSE

dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, monobasic, and sodium phosphate, monobasic, monohydrate

Sponsor: OTSUKA ICU MEDCL

APPLICATION
NDA019513
TYPE
NDA
ORIGINAL APPROVAL
1986-05-08
LATEST ACTION
2013-09-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 141MG/100ML, POTASSIUM PHOSPHATE, MONOBASIC 15MG/100ML, SODIUM LACTATE 260MG/100ML, SODIUM PHOSPHATE, MONOBASIC ANHYDROUS 25MG/100ML · INJECTABLE · INJECTION

Approval history

2013-09-05Manufacturing (CMC) · Supplement 45 · standardAP
2000-06-20Labeling · Supplement 17 · standardAP
2000-02-11Labeling · Supplement 21 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 20 · standardAP
1998-06-22Manufacturing (CMC) · Supplement 19 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 18 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 13 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 12 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 16 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 15 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 14 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 10 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 9 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 6 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 7 · standardAP
1989-09-13Manufacturing (CMC) · Supplement 3 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 2 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 1 · standardAP
1986-05-08Type 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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