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Generated: January 23, 2019

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Details for New Drug Application (NDA): 022485

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NDA 022485 describes ARGATROBAN IN SODIUM CHLORIDE, which is a drug marketed by Eagle Pharms, Gland Pharma Ltd, Sandoz, and Aurobindo Pharma Ltd, and is included in four NDAs. It is available from four suppliers. There are two patents protecting this drug. Additional details are available on the ARGATROBAN IN SODIUM CHLORIDE profile page.

The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 022485
Formulation / Manufacturing:see details
Pharmacology for NDA: 022485
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 022485
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022485 NDA Sandoz Inc 0781-3285 0781-3285-12 2 VIAL, SINGLE-USE in 1 CARTON (0781-3285-12) > 125 mL in 1 VIAL, SINGLE-USE (0781-3285-54)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength125MG/125ML (1MG/ML)
Approval Date:May 9, 2011TE:APRLD:Yes

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