Trihexyphenidyl Hydrochloride

Treats all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). ANDA 84363, held by Watson Labs. Trihexyphenidyl Hydrochloride.

As of Nov 15, 2026, ANDA 84363 (Trihexyphenidyl Hydrochloride), held by Watson Labs, was first approved by FDA on Nov 26, 1974, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 26, 1974
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS This drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic, and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Nov 26, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trihexyphenidyl Hydrochloride2MG · tablet;oral	Trihexyphenidyl Hydrochloride	Rx

All 15 submissions, including labeling and manufacturing supplements


Aug 13, 2001	Supplement 59Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 58Manufacturing	Approved	None posted
Dec 11, 1997	Supplement 52Manufacturing	Approved	None posted
Oct 8, 1997	Supplement 56Manufacturing	Approved	None posted
Sep 2, 1997	Supplement 53Manufacturing	Approved	None posted
Sep 2, 1997	Supplement 54Manufacturing	Approved	None posted
Sep 2, 1997	Supplement 55Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 49Manufacturing	Approved	None posted
Nov 14, 1988	Supplement 44Labeling	Approved	None posted
Jan 28, 1985	Supplement 38Manufacturing	Approved	None posted
Jan 28, 1985	Supplement 39Manufacturing	Approved	None posted
Jan 28, 1985	Supplement 40Manufacturing	Approved	None posted
Feb 9, 1984	Supplement 36Manufacturing	Approved	None posted
Nov 30, 1982	Supplement 35Manufacturing	Approved	None posted
Nov 26, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 84363
Drugs@FDA: Overview at FDA
Company: Watson 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