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FDA NDA · NDA018254
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
NDA018254
TYPE
NDA
ORIGINAL APPROVAL
1980-01-15
LATEST ACTION
1999-10-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 860MG/100ML · INJECTABLE · INJECTION
Approval history
1999-10-28Labeling · Supplement 68AP
1999-10-12Labeling · Supplement 65AP
1998-12-01Manufacturing (CMC) · Supplement 67 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 66 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 61 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 60 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 64 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 63 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 62 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 56 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 55 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 57 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 52 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 53 · standardAP
1989-06-22Manufacturing (CMC) · Supplement 28 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 49 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 48 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 47 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 46 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 43 · standardAP
1985-11-29Labeling · Supplement 32AP
1985-11-29Manufacturing (CMC) · Supplement 31 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 30 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 39 · standardAP
1985-10-26Labeling · Supplement 41AP
1985-09-26Manufacturing (CMC) · Supplement 34 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 45 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 40 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 29 · standardAP
1984-11-09Manufacturing (CMC) · Supplement 38 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 35 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 25 · standardAP
1984-10-10Labeling · Supplement 21AP
1984-10-10Manufacturing (CMC) · Supplement 20 · standardAP
1984-04-09Manufacturing (CMC) · Supplement 27 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 24 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 18 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 22 · standardAP
1983-12-08Manufacturing (CMC) · Supplement 23 · standardAP
1983-10-25Manufacturing (CMC) · Supplement 26 · 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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