Robengatope

NDA 16224, held by Bracco. Rose Bengal Sodium I-131.

As of Nov 14, 2026, NDA 16224 (Robengatope), held by Bracco, was first approved by FDA on Nov 23, 1971, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 23, 1971
Review: Priority
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Nov 23, 1971	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Robengatope0.5mCi/VIAL · injectable;injection	Rose Bengal Sodium I-131	Discontinued
Robengatope1mCi/VIAL · injectable;injection	Rose Bengal Sodium I-131	Discontinued
Robengatope2mCi/VIAL · injectable;injection	Rose Bengal Sodium I-131	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 13Labeling	Approved	None posted
Jun 11, 1982	Supplement 11Manufacturing · Priority review	Approved	None posted
Dec 7, 1976	Supplement 5Manufacturing · Priority review	Approved	None posted
Dec 1, 1976	Supplement 4Labeling	Approved	None posted
Nov 23, 1971	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 16224
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