← FDA DRUG APPROVALS

FDA NDA · NDA018271

ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA018271
TYPE
NDA
ORIGINAL APPROVAL
1980-10-03
LATEST ACTION
1990-09-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
CALCIUM CHLORIDE 37MG/100ML, DEXTROSE 5GM/100ML, MAGNESIUM CHLORIDE 31MG/100ML, POTASSIUM CHLORIDE 120MG/100ML, SODIUM ACETATE 330MG/100ML, SODIUM CHLORIDE 88MG/100ML · INJECTABLE · INJECTION

Approval history

1990-09-11Manufacturing (CMC) · Supplement 16 · standardAP
1987-12-28Labeling · Supplement 14 · standardAP
1987-07-09Labeling · Supplement 13 · standardAP
1986-02-18Manufacturing (CMC) · Supplement 9 · standardAP
1986-02-14Labeling · Supplement 12 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 10 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 11 · standardAP
1984-12-10Manufacturing (CMC) · Supplement 6 · standardAP
1983-01-17Labeling · Supplement 8 · standardAP
1981-12-16Labeling · Supplement 5 · standardAP
1981-10-26Manufacturing (CMC) · Supplement 7 · standardAP
1981-01-02Manufacturing (CMC) · Supplement 1 · standardAP
1980-12-30Manufacturing (CMC) · Supplement 4 · standardAP
1980-12-11Manufacturing (CMC) · Supplement 2 · standardAP
1980-12-10Manufacturing (CMC) · Supplement 3 · standardAP
1980-10-03Type 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 →