Gantanol

NDA 13664, held by Roche. Sulfamethoxazole.

As of Nov 13, 2026, NDA 13664 (Gantanol), held by Roche, was first approved by FDA on Jul 1, 1965, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 1, 1965
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 1, 1965	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gantanol500MG/5ML · suspension;oral	Sulfamethoxazole	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jan 9, 1997	Supplement 19Labeling	Approved	None posted
Jan 9, 1997	Supplement 20Labeling	Approved	None posted
Jan 5, 1978	Supplement 18Labeling	Approved	None posted
Jul 1, 1965	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 13664
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