← FDA DRUG APPROVALS
FDA NDA · NDA018096
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Sponsor: HOSPIRA
APPLICATION
NDA018096
TYPE
NDA
ORIGINAL APPROVAL
1979-08-17
LATEST ACTION
2002-07-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2002-07-18Labeling · Supplement 74 · standardAP
1999-03-31Labeling · Supplement 73 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 72 · standardAP
1997-08-20Labeling · Supplement 70 · standardAP
1997-06-11Manufacturing (CMC) · Supplement 71 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 66 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 65 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 69 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 68 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 67 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 64 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 60 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 59 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 61 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 56 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 57 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 34 · standardAP
1987-07-30Manufacturing (CMC) · Supplement 53 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 52 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 51 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 48 · standardAP
1985-11-29Labeling · Supplement 38 · standardAP
1985-11-29Manufacturing (CMC) · Supplement 37 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 36 · standardAP
1985-10-26Labeling · Supplement 46 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 44 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 40 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 50 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 45 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 35 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 41 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 31 · standardAP
1984-10-10Manufacturing (CMC) · Supplement 26 · standardAP
1984-10-10Labeling · Supplement 27 · standardAP
1984-04-09Manufacturing (CMC) · Supplement 33 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 30 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 24 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 28 · standardAP
1983-12-08Manufacturing (CMC) · Supplement 29 · standardAP
1983-10-25Manufacturing (CMC) · Supplement 32 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.