Chenix

NDA 18513, held by Leadiant Biosci Inc. Chenodiol.

As of Nov 13, 2026, NDA 18513 (Chenix), held by Leadiant Biosci Inc, was first approved by FDA on Jul 28, 1983, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1983
Review: Priority
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
Jul 28, 1983	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chenix250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Chenodiol	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


May 20, 2010	Supplement 12Labeling	Approved	Letter
Jan 3, 1990	Supplement 11Labeling	Approved	None posted
Nov 16, 1988	Supplement 10Labeling	Approved	None posted
Dec 22, 1986	Supplement 9Labeling	Approved	None posted
Apr 25, 1986	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 25, 1986	Supplement 2Manufacturing · Priority review	Approved	None posted
Apr 24, 1986	Supplement 8Labeling	Approved	None posted
Dec 18, 1984	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 17, 1984	Supplement 6Manufacturing · Priority review	Approved	None posted
Apr 17, 1984	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 28, 1983	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 18513
Drugs@FDA: Overview at FDA
Company: Leadiant Biosciences

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