← FDA DRUG APPROVALS

FDA NDA · NDA019870

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: B BRAUN

APPLICATION
NDA019870
TYPE
NDA
ORIGINAL APPROVAL
1993-06-10
LATEST ACTION
2004-05-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML, POTASSIUM PHOSPHATE, DIBASIC 130MG/100ML, SODIUM ACETATE 280MG/100ML, SODIUM CHLORIDE 91MG/100ML · INJECTABLE · INJECTION

Approval history

2004-05-11Labeling · Supplement 9AP
2002-07-01Manufacturing (CMC) · Supplement 8 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 6 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 5 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 4 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 3 · standardAP
1995-09-13Manufacturing (CMC) · Supplement 2 · standardAP
1994-06-01Labeling · Supplement 1AP
1993-06-10Type 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 →