Travasol 3.5% Sulfite Free W/ Electrolytes In Plastic Container

NDA 20177, held by Baxter Hlthcare. Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 20177 (Travasol 3.5% Sulfite Free W/ Electrolytes In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Oct 23, 1995, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 23, 1995
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 23, 1995	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Travasol 3.5% Sulfite Free W/ Electrolytes In Plastic Container3.5%;51MG/100ML;131MG/100ML;218MG/100ML;35MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 29, 2002	Supplement 11Labeling · Standard review	Approved	None posted
Aug 29, 2001	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 10, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 28, 2001	Supplement 7Labeling · Standard review	Approved	None posted
Jun 9, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 28, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 11, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 11, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 18, 1997	Supplement 2Manufacturing · 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 20177
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