Hydroxystilbamidine Isethionate

NDA 9166, held by Sanofi Aventis US. Hydroxystilbamidine Isethionate.

As of Nov 13, 2026, NDA 9166 (Hydroxystilbamidine Isethionate), held by Sanofi Aventis US, was first approved by FDA on Dec 22, 1953, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1953
Review: Standard
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
Dec 22, 1953	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydroxystilbamidine Isethionate225MG/AMP · injectable;injection	Hydroxystilbamidine Isethionate	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 19, 1987	Supplement 8Labeling · Standard review	Approved	None posted
May 12, 1980	Supplement 6Labeling · Standard review	Approved	None posted
May 12, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 12, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Dec 22, 1953	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 9166
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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