Cholebrine

NDA 17129, held by Mallinckrodt. Iocetamic Acid.

As of Nov 14, 2026, NDA 17129 (Cholebrine), held by Mallinckrodt, was first approved by FDA on May 16, 1973, with 2 approved supplements and 0 published complete response letters.

First approved: May 16, 1973
Review: Standard
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
May 16, 1973	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cholebrine750MG · tablet;oral	Iocetamic Acid	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 25, 1997	Supplement 5Labeling	Approved	None posted
Aug 25, 1997	Supplement 6Labeling	Approved	None posted
May 16, 1973	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17129
Drugs@FDA: Overview at FDA
Company: Mallinckrodt

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