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Generated: November 17, 2018

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Details for New Drug Application (NDA): 205570

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NDA 205570 describes ARGATROBAN IN SODIUM CHLORIDE, which is a drug marketed by Eagle Pharms, Gland Pharma Ltd, and Sandoz, and is included in three NDAs. It is available from three 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. Ten suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 205570
Tradename:ARGATROBAN IN SODIUM CHLORIDE
Applicant:Gland Pharma Ltd
Ingredient:argatroban
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205570
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 205570
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 205570 ANDA Gland Pharma Limited 68083-141 68083-141-02 2 VIAL in 1 CARTON (68083-141-02) > 125 mL in 1 VIAL (68083-141-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength125MG/125ML (1MG/ML)
Approval Date:May 22, 2017TE:APRLD:No

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