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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 209552


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NDA 209552 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. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 209552
Tradename:ARGATROBAN IN SODIUM CHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:argatroban
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209552
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 209552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN IN SODIUM CHLORIDE argatroban SOLUTION;INTRAVENOUS 209552 NDA AuroMedics Pharma LLC 55150-241 55150-241-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-241-10) > 50 mL in 1 VIAL, SINGLE-DOSE (55150-241-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/50ML (1MG/ML)
Approval Date:Nov 27, 2018TE:RLD:No

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