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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 201811

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NDA 201811 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Caplin, Fresenius Kabi Usa, Gland, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Ph Health, Sandoz, Teva Pharms Usa, Cipla, Plano Pharms, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen NDAs. It is available from eight suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the argatroban profile page.

Summary for 201811

Tradename:	ARGATROBAN
Applicant:	Fresenius Kabi Usa
Ingredient:	argatroban
Patents:	0

Pharmacology for NDA: 201811

Mechanism of Action	Thrombin Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	250MG/2.5ML (100MG/ML)
Approval Date:	Mar 23, 2015	TE:		RLD:	No

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