Ornidyl

NDA 19879, held by Sanofi Aventis US. Eflornithine Hydrochloride.

As of Nov 14, 2026, NDA 19879 (Ornidyl), held by Sanofi Aventis US, was first approved by FDA on Nov 28, 1990, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 28, 1990
Review: Priority
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 28, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ornidyl200MG/ML · injectable;injection	Eflornithine Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 3, 2002	Supplement 2Manufacturing · Priority review	Approved	None posted
Apr 17, 1995	Supplement 1Manufacturing · Priority review	Approved	None posted
Nov 28, 1990	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19879
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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