Hippuran I 131

NDA 16666, held by Mallinckrodt. Iodohippurate Sodium I-131.

As of Nov 14, 2026, NDA 16666 (Hippuran I 131), held by Mallinckrodt, was first approved by FDA on May 24, 1968, with 7 approved supplements and 0 published complete response letters.

First approved: May 24, 1968
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 24, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hippuran I 1310.25mCi/ML · injectable;injection	Iodohippurate Sodium I-131	Discontinued

All 8 submissions, including labeling and manufacturing supplements


May 15, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 16, 1982	Supplement 12Labeling · Standard review	Approved	None posted
May 7, 1982	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 7, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 23, 1977	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 27, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 19, 1975	Supplement 6Labeling · Standard review	Approved	None posted
May 24, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16666
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