Arfonad

NDA 8983, held by Roche. Trimethaphan Camsylate.

As of Nov 14, 2026, NDA 8983 (Arfonad), held by Roche, was first approved by FDA on Apr 26, 1954, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1954
Review: Priority
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
Apr 26, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Arfonad50MG/ML · injectable;injection	Trimethaphan Camsylate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 21, 1988	Supplement 11Labeling	Approved	None posted
Jun 26, 1978	Supplement 10Labeling	Approved	None posted
May 6, 1976	Supplement 9Labeling	Approved	None posted
Apr 26, 1954	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 8983
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