Gantrisin, Gantrisin Pediatric, Lipo Gantrisin

NDA 9182, held by Roche. Sulfisoxazole Acetyl.

As of Nov 13, 2026, NDA 9182 (Gantrisin, Gantrisin Pediatric, Lipo Gantrisin), held by Roche, was first approved by FDA on Dec 4, 1953, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 4, 1953
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
Dec 4, 1953	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
GantrisinEQ 500MG BASE/5ML · syrup;oral	Sulfisoxazole Acetyl	Discontinued
Gantrisin PediatricEQ 500MG BASE/5ML · suspension;oral	Sulfisoxazole Acetyl	Discontinued
Lipo GantrisinEQ 1GM BASE/5ML · emulsion;oral	Sulfisoxazole Acetyl	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 23, 1996	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 31, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 4, 1993	Supplement 17Labeling · Standard review	Approved	None posted
May 25, 1982	Supplement 16Labeling · Standard review	Approved	None posted
Jan 27, 1978	Supplement 14Labeling · Standard review	Approved	None posted
Dec 22, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 11, 1975	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 4, 1953	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 9182
Drugs@FDA: Overview at FDA
Company: Roche

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