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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKesson
Express Scripts
Cipla
Citi
Moodys
Fuji
Colorcon

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201811

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NDA 201811 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis Pharms Corp, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd, and is included in twelve 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. Twelve 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 201811
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 201811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN argatroban INJECTABLE;INJECTION 201811 NDA Fresenius Kabi USA, LLC 63323-526 N 63323-526-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Mar 23, 2015TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Accenture
Boehringer Ingelheim
Deloitte
Johnson and Johnson
Julphar
Moodys
Express Scripts
US Department of Justice

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