Orange Book product
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100M…
Orange Book NDA 020171 · FRESENIUS MEDICAL CARE NORTH AMERICA · Prescription
Key facts
| Proprietary name | DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE |
| Strength | 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML |
| Dosage form | SOLUTION |
| Route | INTRAPERITONEAL |
| Application | NDA020171 |
| Applicant holder | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AT |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Aug 19, 1992 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.