Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 5% In Plastic Container, Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 10% In Plastic Container, Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 15% In Plastic Container

NDA 20147, held by Baxter Hlthcare. Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 20147 (Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 5% In Plastic Container, Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 10% In Plastic Container, Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 15% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Oct 23, 1995, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 23, 1995
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 12, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 23, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

10 strengths and forms

Product	Active ingredient	Marketing
Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 5% In Plastic Container2.75%;5GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 10% In Plastic Container2.75%;10GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 15% In Plastic Container2.75%;15GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 20% In Plastic Container2.75%;20GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 2.75% Sulfite Free W/ Electrolytes In Dextrose 25% In Plastic Container2.75%;25GM/100ML;51MG/100ML;261MG/100ML;216MG/100ML;112MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 5% In Plastic Container4.25%;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 10% In Plastic Container4.25%;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 15% In Plastic Container4.25%;15GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 20% In Plastic Container4.25%;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued
Travasol 4.25% Sulfite Free W/ Electrolytes In Dextrose 25% In Plastic Container4.25%;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML · injectable;injection	Amino Acids; Dextrose; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 14, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 12, 2000	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Mar 24, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 24, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 31, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 6, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 9, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Apr 29, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 23, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20147
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters