Argatroban

Treats thrombosis. Sold as Argatroban, Argatroban In Sodium Chloride, Argatroban In Dextrose, Argatroban In 0.9% Sodium Chloride. Every FDA application for this active ingredient: 10 branded and 8 generic.

As of Nov 15, 2026, FDA lists 18 applications for Argatroban (sold as Argatroban, Argatroban In Sodium Chloride, Argatroban In Dextrose and others), first approved Jun 30, 2000, with 2 new uses approved and 0 published complete response letters.

First approved: Jun 30, 2000
Applications: 18
New uses approved: 2
Complete response letters: 0

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Novastan HIDrugs with new additional indications and new dosages for the prevention of perfusion blood coagulation during blood extracorporeal circulation… · Daiichi Sankyo Company, Limited · May 20, 2011
Novastan HIDrugs with a new indication and a new dosage for prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia (HIT) type II. · Daiichi Sankyo Co., Ltd. · Jul 16, 2008

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMOPneumonia, Heart Failure · University Hospital Ostrava	Phase 2	Not yet recruiting	Mar 27, 2026
HEPARINS: INTERFERENCE IN ARGATROBAN MEASUREMENTThromboembolic Disease · University Hospital, Strasbourg, France	—	Recruiting	Dec 24, 2025
Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO SupportRespiratory Insufficiency, Circulatory Failure · Medical University of Vienna	Phase 4	Recruiting	Jun 4, 2024

Applications

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


Jun 30, 2000	ArgatrobanNDA 20883 · New molecular entity	Sandoz	12	Discontinued
May 9, 2011	Argatroban In Sodium ChlorideNDA 22485 · New formulation or manufacturer	Plano Pharms	6	Marketed
May 9, 2011	Argatroban In DextroseNDA 201743 · New formulation or manufacturer	Sandoz	3	Discontinued
Jun 29, 2011	Argatroban In Sodium ChlorideNDA 22434 · New formulation or manufacturer	Cipla	10	Discontinued
Jan 5, 2012	ArgatrobanNDA 203049 · New formulation or manufacturer	Hikma Pharm Co Ltd	6	Marketed
Jun 30, 2014	ArgatrobanANDA 91665	Ph Health	0	Marketed
Jun 30, 2014	ArgatrobanANDA 202626	Mylan Institutional	2	Marketed
Dec 15, 2014	Argatroban In 0.9% Sodium ChlorideNDA 206769 · New formulation or manufacturer	Teva Pharms USA	4	Discontinued
Mar 23, 2015	ArgatrobanNDA 201811 · New formulation or manufacturer	Fresenius Kabi USA	4	Discontinued
Sep 21, 2016	ArgatrobanANDA 204120	Hospira	1	Discontinued
May 22, 2017	Argatroban In Sodium ChlorideANDA 205570	Gland	0	Marketed
Jan 26, 2018	ArgatrobanANDA 206698	Amneal Pharms Co	0	Marketed
Nov 27, 2018	Argatroban In Sodium ChlorideNDA 209552 · New formulation or manufacturer	Eugia Pharma Speclts	1	Marketed
Jan 21, 2021	ArgatrobanANDA 214235	Caplin	1	Marketed
Jun 7, 2021	Argatroban In Sodium ChlorideNDA 212035 · New formulation or manufacturer	Accord Hlthcare	2	Marketed
Jul 31, 2023	ArgatrobanANDA 217848	Gland	0	Marketed
—	ArgatrobanANDA 79238	Pliva Hrvatska Doo	0	Discontinued
—	ArgatrobanNDA 22359	Baxter Hlthcare Corp	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