Trihexyphenidyl Hydrochloride

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
May 13, 1949	ArtaneNDA 6773	Lederle	22	Discontinued
Apr 18, 1962	ArtaneNDA 12947 · New dosage form	Lederle	6	Discontinued
Nov 26, 1974	Trihexyphenidyl HydrochlorideANDA 84363	Watson Labs	14	Marketed
Dec 6, 1974	Trihexyphenidyl HydrochlorideANDA 84364	Watson Labs	15	Marketed
Jul 30, 1982	Trihexyphenidyl HydrochlorideANDA 88035	Vangard	1	Discontinued
Apr 7, 1989	Trihexyphenidyl HydrochlorideANDA 89514	Pharm Ventures	2	Discontinued
Apr 17, 1997	Trihexyphenidyl HydrochlorideANDA 40177	Pharm Assoc	2	Marketed
Feb 6, 1998	Trihexyphenidyl HydrochlorideANDA 40184	Watson Labs	0	Discontinued
Dec 24, 1998	Trihexyphenidyl HydrochlorideANDA 40254	Novitium Pharma	2	Marketed
Sep 27, 1999	Trihexyphenidyl HydrochlorideANDA 40251	Chartwell Rx	2	Marketed
Feb 16, 2000	Trihexyphenidyl HydrochlorideANDA 40337	Hikma	3	Discontinued
Nov 17, 2010	Trihexyphenidyl HydrochlorideANDA 91630	Natco Pharma Ltd	0	Marketed
—	TreminANDA 80381	Schering	0	Discontinued
—	Trihexyphenidyl HydrochlorideANDA 85105	Watson Labs	0	Discontinued
—	Trihexyphenidyl HydrochlorideANDA 85117	Watson Labs	0	Discontinued
—	Trihexyphenidyl HydrochlorideANDA 85622	Nylos	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA