Travamulsion 10%

NDA 18660, held by Baxter Hlthcare. Soybean Oil.

As of Nov 14, 2026, NDA 18660 (Travamulsion 10%), held by Baxter Hlthcare, was first approved by FDA on Feb 26, 1982, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1982
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 26, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Travamulsion 10%10% · injectable;injection	Soybean Oil	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jul 18, 1986	Supplement 9Labeling	Approved	None posted
Sep 19, 1985	Supplement 5Labeling	Approved	None posted
Aug 19, 1985	Supplement 6Labeling	Approved	None posted
Nov 2, 1983	Supplement 2Labeling	Approved	None posted
Feb 26, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18660
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