Selegiline Hydrochloride

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jun 5, 1989	Selegiline HydrochlorideNDA 19334 · New molecular entity	Quagen	13	Discontinued
May 15, 1996	EldeprylNDA 20647 · New dosage form	Quagen	5	Discontinued
Aug 2, 1996	Selegiline HydrochlorideANDA 74537	G And W Labs Inc	3	Discontinued
Aug 2, 1996	Selegiline HydrochlorideANDA 74565	Chartwell Molecules	7	Discontinued
Aug 2, 1996	Selegiline HydrochlorideANDA 74641	Chartwell Molecules	6	Discontinued
Jan 27, 1997	Selegiline HydrochlorideANDA 74744	Cosette Pharms Nc	6	Discontinued
Apr 1, 1997	Selegiline HydrochlorideANDA 74672	Pharmazone	0	Marketed
Jun 6, 1997	Selegiline HydrochlorideANDA 74871	Apotex	5	Marketed
Nov 26, 1997	Selegiline HydrochlorideANDA 74866	Novitium Pharma	1	Discontinued
Apr 30, 1998	Selegiline HydrochlorideANDA 74912	Kenton	3	Discontinued
Nov 25, 1998	Selegiline HydrochlorideANDA 74756	Cosette Pharms Nc	0	Discontinued
Nov 30, 1998	Selegiline HydrochlorideANDA 75352	Novitium Pharma	1	Marketed
Dec 4, 1998	Selegiline HydrochlorideANDA 75321	Apotex	4	Marketed
Sep 15, 2003	Selegiline HydrochlorideANDA 75145	Lannett Co Inc	0	Discontinued
Jun 14, 2006	ZelaparNDA 21479 · New dosage form	Bausch	6	Discontinued
Apr 2, 2019	Selegiline HydrochlorideANDA 206803	Rising	0	Marketed

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