Pathilon

NDA 9489, held by Lederle. Tridihexethyl Chloride.

As of Nov 13, 2026, NDA 9489 (Pathilon), held by Lederle, was first approved by FDA on Sep 15, 1954, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 15, 1954
Review: Standard
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
Sep 15, 1954	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pathilon25MG · tablet;oral	Tridihexethyl Chloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 7, 1991	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 9, 1990	Supplement 24Labeling · Standard review	Approved	None posted
Mar 27, 1989	Supplement 23Labeling · Standard review	Approved	None posted
Sep 28, 1988	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 16, 1987	Supplement 21Labeling · Standard review	Approved	None posted
Sep 15, 1954	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 9489
Drugs@FDA: Overview at FDA
Company: Lederle Laboratories

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