Tral

NDA 10599, held by Abbvie. Hexocyclium Methylsulfate.

As of Nov 13, 2026, NDA 10599 (Tral), held by Abbvie, was first approved by FDA on Feb 13, 1957, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 13, 1957
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
Feb 13, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tral25MG · tablet;oral	Hexocyclium Methylsulfate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Apr 14, 1988	Supplement 14Labeling	Approved	None posted
Oct 7, 1980	Supplement 12Labeling	Approved	None posted
Oct 7, 1980	Supplement 11Labeling	Approved	None posted
Oct 7, 1980	Supplement 10Labeling	Approved	None posted
Feb 13, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10599
Drugs@FDA: Overview at FDA
Company: AbbVie

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