Gantrisin

As of Nov 13, 2026, NDA 6525 (Gantrisin), held by Roche, was first approved by FDA on Jul 29, 1948, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1948
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
Jul 29, 1948	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gantrisin500MG · tablet;oral	Sulfisoxazole	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 9, 1997	Supplement 18Labeling	Approved	None posted
Aug 4, 1993	Supplement 20Labeling	Approved	None posted
May 25, 1982	Supplement 17Labeling	Approved	None posted
Jul 12, 1978	Supplement 16Labeling	Approved	None posted
Jan 27, 1978	Supplement 15Labeling	Approved	None posted
Jul 29, 1948	Original application	Approved	None posted

Identifiers

Application: NDA 6525
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