FDA approval · Drugs@FDA
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINERcalcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate
NDA020163 ·
FDA approved the original new drug application for DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER on December 4, 1992, sponsored by VANTIVE US HLTHCARE. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA020163
- Sponsor
- VANTIVE US HLTHCARE
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate
Browse every approval whose brand starts with D, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| calcium chloride 25.7MG/100ML; dextrose 4.25GM/100ML; magnesium chloride 5.08MG/100ML; sodium chloride 538MG/100ML; sodium lactate 448MG/100ML | SOLUTION | INTRAPERITONEAL | Prescription |
| calcium chloride 25.7MG/100ML; dextrose 1.5GM/100ML; magnesium chloride 5.08MG/100ML; sodium chloride 538MG/100ML; sodium lactate 448MG/100ML | SOLUTION | INTRAPERITONEAL | Prescription |
| calcium chloride 25.7MG/100ML; dextrose 2.5GM/100ML; magnesium chloride 5.08MG/100ML; sodium chloride 538MG/100ML; sodium lactate 448MG/100ML | SOLUTION | INTRAPERITONEAL | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 12 · Labeling 6. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to VANTIVE US HLTHCARE
- January 13, 2015PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINERNDA207026
- October 25, 2006PRISMASOL B22GK 2/0 IN PLASTIC CONTAINERNDA021703
- December 20, 2002EXTRANEALNDA021321
- December 4, 1992DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINERNDA020183
- September 27, 1978DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINERNDA017512
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