← FDA DRUG APPROVALS
FDA NDA · NDA017609
NORMOSOL-R AND DEXTROSE
dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA017609
TYPE
NDA
ORIGINAL APPROVAL
1975-08-13
LATEST ACTION
2013-09-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 222MG/100ML, SODIUM CHLORIDE 526MG/100ML, SODIUM GLUCONATE 502MG/100ML · INJECTABLE · INJECTION
Approval history
2013-09-05Manufacturing (CMC) · Supplement 127 · standardAP
2000-06-20Labeling · Supplement 107 · standardAP
2000-06-15Labeling · Supplement 110 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 109 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 108 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 103 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 102 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 106 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 105 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 104 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 98 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 97 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 99 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 94 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 95 · standardAP
1989-06-22Manufacturing (CMC) · Supplement 67 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 91 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 90 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 89 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 88 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 85 · standardAP
1985-11-29Labeling · Supplement 71AP
1985-11-29Manufacturing (CMC) · Supplement 70 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 69 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 78 · standardAP
1985-10-26Labeling · Supplement 82AP
1985-09-26Manufacturing (CMC) · Supplement 73 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 87 · standardAP
1985-05-14Manufacturing (CMC) · Supplement 84 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 81 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 68 · standardAP
1984-11-16Labeling · Supplement 80AP
1984-11-16Manufacturing (CMC) · Supplement 79 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 77 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 74 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 64 · standardAP
1984-10-10Labeling · Supplement 59AP
1984-10-10Manufacturing (CMC) · Supplement 58 · standardAP
1984-04-09Manufacturing (CMC) · Supplement 66 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 63 · standardAP
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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