← FDA DRUG APPROVALS
FDA NDA · NDA017610
NORMOSOL-M AND DEXTROSE
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA017610
TYPE
NDA
ORIGINAL APPROVAL
1975-08-13
LATEST ACTION
2014-09-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, MAGNESIUM ACETATE 21MG/100ML, POTASSIUM ACETATE 128MG/100ML, SODIUM CHLORIDE 234MG/100ML · INJECTABLE · INJECTION
Approval history
2014-09-08Manufacturing (CMC) · Supplement 119 · standardAP
1999-07-29Labeling · Supplement 102AP
1998-12-01Manufacturing (CMC) · Supplement 104 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 103 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 98 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 97 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 101 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 100 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 99 · standardAP
1994-08-09Manufacturing (CMC) · Supplement 65 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 93 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 92 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 94 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 89 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 90 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 86 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 85 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 84 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 81 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 68 · standardAP
1985-11-29Labeling · Supplement 69AP
1985-10-29Manufacturing (CMC) · Supplement 67 · standardAP
1985-10-26Labeling · Supplement 79AP
1985-10-26Manufacturing (CMC) · Supplement 75 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 71 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 83 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 78 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 66 · standardAP
1984-11-16Manufacturing (CMC) · Supplement 76 · standardAP
1984-11-16Labeling · Supplement 77AP
1984-10-22Manufacturing (CMC) · Supplement 72 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 62 · standardAP
1984-10-10Labeling · Supplement 58AP
1984-10-10Manufacturing (CMC) · Supplement 57 · standardAP
1984-04-09Manufacturing (CMC) · Supplement 64 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 61 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 55 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 59 · standardAP
1983-12-08Manufacturing (CMC) · Supplement 60 · standardAP
1983-10-25Manufacturing (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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