FDA approval · Drugs@FDA
CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINERamino acids, calcium chloride, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride
NDA020678 ·
FDA approved the original new drug application for CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER on March 26, 1997, sponsored by BAXTER HLTHCARE. FDA has approved 1 efficacy supplement on the application since, the most recent on April 12, 2000.
- Application
- NDA020678
- Sponsor
- BAXTER HLTHCARE
- Original approval
- Review
- standard review
- Submission class
- Type 4 - New Combination
- Active ingredient
- amino acids, calcium chloride, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride
Browse every approval whose brand starts with C, 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 |
|---|---|---|---|
| amino acids 5%; calcium chloride 33MG/100ML; dextrose 20GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 340MG/100ML; sodium chloride 59MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 5%; calcium chloride 33MG/100ML; dextrose 10GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 340MG/100ML; sodium chloride 59MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 4.25%; calcium chloride 33MG/100ML; dextrose 5GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 4.25%; calcium chloride 33MG/100ML; dextrose 25GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 2.75%; calcium chloride 33MG/100ML; dextrose 10GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 217MG/100ML; sodium chloride 112MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 5%; calcium chloride 33MG/100ML; dextrose 25GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 340MG/100ML; sodium chloride 59MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 5%; calcium chloride 33MG/100ML; dextrose 15GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 340MG/100ML; sodium chloride 59MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 4.25%; calcium chloride 33MG/100ML; dextrose 10GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 5%; calcium chloride 33MG/100ML; dextrose 35GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 340MG/100ML; sodium chloride 59MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 2.75%; calcium chloride 33MG/100ML; dextrose 25GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 217MG/100ML; sodium chloride 112MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 4.25%; calcium chloride 33MG/100ML; dextrose 20GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100ML | INJECTABLE | INJECTION | Prescription |
| amino acids 2.75%; calcium chloride 33MG/100ML; dextrose 5GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 217MG/100ML; sodium chloride 112MG/100ML | INJECTABLE | INJECTION | 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.
| Approved | Supplement | Review |
|---|---|---|
| S-3 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 15 · Labeling 5. 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 BAXTER HLTHCARE
- December 24, 2008NEXTERONENDA022325
- August 5, 2008CEFEPIME IN PLASTIC CONTAINERNDA050817
- March 21, 2002MESNEXNDA020855
- August 26, 1998PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERNDA020849
- September 29, 1997CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINERNDA020734
- October 27, 1995TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINERNDA020173
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