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Last Updated: April 16, 2021

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Details for New Drug Application (NDA): 022434

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NDA 022434 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 022434
Tradename:ARGATROBAN IN SODIUM CHLORIDE
Applicant:Eagle Pharms
Ingredient:argatroban
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022434
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 022434
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022434 NDA Sandoz Inc 0781-3314 0781-3314-95 10 CARTON in 1 CARTON (0781-3314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-3314-91) > 50 mL in 1 VIAL, SINGLE-USE
ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022434 NDA Sandoz Inc 0781-9314 0781-9314-95 10 CARTON in 1 CARTON (0781-9314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-9314-91) > 50 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 022434
Tradename Dosage Ingredient NDA Submissiondate
ARGATROBAN IN SODIUM CHLORIDE INJECTABLE;INTRAVENOUS argatroban 022434 2011-12-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength50MG/50ML (1MG/ML)
Approval Date:Jun 29, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING THROMBOSIS
Patent:  Start TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION

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