← FDA DRUG APPROVALS
FDA NDA · NDA016695
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
Sponsor: BAXTER HLTHCARE
APPLICATION
NDA016695
TYPE
NDA
ORIGINAL APPROVAL
1971-03-23
LATEST ACTION
2001-08-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 33MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 860MG/100ML · INJECTABLE · INJECTION
Approval history
2001-08-14Manufacturing (CMC) · Supplement 89 · standardAP
2000-11-29Labeling · Supplement 86 · standardAP
2000-11-02Labeling · Supplement 88 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 87 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 85 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 83 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 84 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 81 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 80 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 78 · standardAP
1991-01-10Manufacturing (CMC) · Supplement 79 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 77 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 76 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 75 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 73 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 66 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 65 · standardAP
1985-07-03Labeling · Supplement 71 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 70 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 72 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 63 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 69 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 64 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 68 · standardAP
1983-07-11Labeling · Supplement 60 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 57 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 55 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 61 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 53 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 59 · standardAP
1981-11-09Manufacturing (CMC) · Supplement 56 · standardAP
1981-08-26Labeling · Supplement 54 · standardAP
1981-06-29Manufacturing (CMC) · Supplement 51 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 47 · standardAP
1981-01-21Manufacturing (CMC) · Supplement 50 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 43 · standardAP
1980-08-06Manufacturing (CMC) · Supplement 48 · standardAP
1980-07-31Manufacturing (CMC) · Supplement 49 · standardAP
1980-06-28Manufacturing (CMC) · Supplement 41 · standardAP
1980-06-18Manufacturing (CMC) · Supplement 45 · 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.