← FDA DRUG APPROVALS

FDA NDA · NDA017510

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA017510
TYPE
NDA
ORIGINAL APPROVAL
1978-02-08
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 20MG/100ML, DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 30MG/100ML, SODIUM CHLORIDE 600MG/100ML, SODIUM LACTATE 310MG/100ML · INJECTABLE · INJECTION

Approval history

1990-09-11Manufacturing (CMC) · Supplement 25 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 16 · standardAP
1985-11-22Manufacturing (CMC) · Supplement 22 · standardAP
1985-06-25Labeling · Supplement 23 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 17 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 19 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 20 · standardAP
1983-01-24Labeling · Supplement 14 · standardAP
1981-10-26Manufacturing (CMC) · Supplement 15 · standardAP
1980-10-24Manufacturing (CMC) · Supplement 12 · standardAP
1980-09-26Manufacturing (CMC) · Supplement 13 · standardAP
1980-08-06Manufacturing (CMC) · Supplement 11 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 10 · standardAP
1980-02-12Manufacturing (CMC) · Supplement 9 · standardAP
1979-10-16Manufacturing (CMC) · Supplement 7 · standardAP
1979-10-09Labeling · Supplement 8 · standardAP
1979-06-08Manufacturing (CMC) · Supplement 6 · standardAP
1979-01-04Manufacturing (CMC) · Supplement 5 · standardAP
1978-09-29Labeling · Supplement 2 · standardAP
1978-09-29Manufacturing (CMC) · Supplement 3 · standardAP
1978-09-26Manufacturing (CMC) · Supplement 4 · standardAP
1978-03-23Manufacturing (CMC) · Supplement 1 · standardAP
1978-02-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →