Artane

NDA 12947, held by Lederle. Trihexyphenidyl Hydrochloride.

As of Nov 13, 2026, NDA 12947 (Artane), held by Lederle, was first approved by FDA on Apr 18, 1962, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 18, 1962
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Feb 8, 1977	Supplement 11Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 18, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Artane5MG · capsule, extended release;oral	Trihexyphenidyl Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jun 15, 1993	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 24, 1987	Supplement 19Labeling · Standard review	Approved	None posted
Feb 26, 1987	Supplement 20Labeling · Standard review	Approved	None posted
Jun 26, 1984	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 22, 1982	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 8, 1977	Supplement 11Efficacy (new indication or use) · Standard review	Approved	None posted
Apr 18, 1962	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12947
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