Hipputope

NDA 15419, held by Bracco. Iodohippurate Sodium I-131.

As of Nov 13, 2026, NDA 15419 (Hipputope), held by Bracco, was first approved by FDA on Jun 25, 1970, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 25, 1970
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jun 25, 1970	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hipputope1-2mCi/VIAL · injectable;injection	Iodohippurate Sodium I-131	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 7Labeling	Approved	None posted
Mar 13, 2009	Supplement 8Labeling	Approved	None posted
Sep 30, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 12, 1985	Supplement 12Labeling	Approved	None posted
Jun 8, 1983	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 25, 1970	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 15419
Drugs@FDA: Overview at FDA
Company: Bracco

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