All FDA drug approvals

FDA approval · Drugs@FDA

TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINERamino acids, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride

NDA020147 ·

FDA approved the original new drug application for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER on October 23, 1995, sponsored by BAXTER HLTHCARE. FDA marks all 10 products under the application discontinued. FDA has approved 1 efficacy supplement on the application since, the most recent on April 12, 2000.

Application
NDA020147
Sponsor
BAXTER HLTHCARE
Original approval
Review
standard review
Submission class
Type 5 - New Formulation or New Manufacturer
Active ingredient
amino acids, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride

Products under this application

Ingredient and strengthFormRouteMarketing status
amino acids 4.25%; dextrose 15GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 4.25%; dextrose 5GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 2.75%; dextrose 20GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 216MG/100ML; sodium chloride 112MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 4.25%; dextrose 25GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 2.75%; dextrose 10GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 216MG/100ML; sodium chloride 112MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 4.25%; dextrose 20GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 4.25%; dextrose 10GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 297MG/100ML; sodium chloride 77MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 2.75%; dextrose 25GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 216MG/100ML; sodium chloride 112MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 2.75%; dextrose 15GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 216MG/100ML; sodium chloride 112MG/100MLINJECTABLEINJECTIONDiscontinued
amino acids 2.75%; dextrose 5GM/100ML; magnesium chloride 51MG/100ML; potassium phosphate, dibasic 261MG/100ML; sodium acetate 216MG/100ML; sodium chloride 112MG/100MLINJECTABLEINJECTIONDiscontinued

What “discontinued” means in FDA’s record

Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.

Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.

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.

ApprovedSupplementReview
S-6standard

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 6 · Labeling 1. 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.

An approval date is the start of the question, not the end

What a drug is worth to the company that owns it depends on what else is in the pipeline, how much cash is behind it and who else is running the same trial. FuzeBio reads a biotech end to end on demand — pipeline in plain English, trial design and endpoints, competitors, the cash position, and a valuation with its assumptions on the page. Moderna’s report is open in full, no account.

Open the Moderna report

A complete sample report — nothing held back, no sign-up.