Tranylcypromine Sulfate

Treats major depressive disorder (MDD). Sold as Parnate. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 15, 2026, FDA lists 4 applications for Tranylcypromine Sulfate (sold as Parnate), first approved Feb 21, 1961, with 2 new uses approved and 0 published complete response letters.

First approved: Feb 21, 1961
Applications: 4
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $2.8M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Tranylcypromine Sulfate	Part D	$2.4M	-10%	1,754
Parnate	Part D	$450K	-5%	32

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Efficacy of Hydroxyzine for Patients With Panic DisorderPanic Disorder · Sultan Qaboos University	Phase 4	Not yet recruiting	Feb 21, 2023

Applications

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


Feb 21, 1961	ParnateNDA 12342 · New molecular entity	Advanz Pharma	22	Marketed
Jun 29, 2006	Tranylcypromine SulfateANDA 40640	Strides Pharma Intl	4	Marketed
Apr 17, 2018	Tranylcypromine SulfateANDA 206856	Novitium Pharma	0	Marketed
Jun 27, 2022	Tranylcypromine SulfateANDA 213503	Crossmedika SA	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