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FDA NDA · NDA017585
DEXTROSE AND SODIUM CHLORIDE
dextrose monohydrate and sodium chloride
Sponsor: OTSUKA ICU MEDCL
APPLICATION
NDA017585
TYPE
NDA
ORIGINAL APPROVAL
1976-01-07
LATEST ACTION
2015-07-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2015-07-31Manufacturing (CMC) · Supplement 142 · standardAP
2014-09-08Manufacturing (CMC) · Supplement 140 · standardAP
2002-07-18Labeling · Supplement 116AP
1999-03-31Labeling · Supplement 115AP
1998-12-01Manufacturing (CMC) · Supplement 114 · standardAP
1997-08-20Labeling · Supplement 112AP
1997-06-11Manufacturing (CMC) · Supplement 113 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 111 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 107 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 106 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 110 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 109 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 108 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 104 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 100 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 99 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 101 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 96 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 97 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 72 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 93 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 92 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 91 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 88 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 75 · standardAP
1985-11-29Labeling · Supplement 76AP
1985-10-29Manufacturing (CMC) · Supplement 74 · standardAP
1985-10-26Labeling · Supplement 84AP
1985-10-26Manufacturing (CMC) · Supplement 82 · standardAP
1985-09-30Manufacturing (CMC) · Supplement 89 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 78 · standardAP
1985-08-27Manufacturing (CMC) · Supplement 85 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 90 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 83 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 73 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 79 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 69 · standardAP
1984-10-10Labeling · Supplement 63AP
1984-10-10Manufacturing (CMC) · Supplement 62 · standardAP
1984-06-14Manufacturing (CMC) · Supplement 70 · 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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