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Details for NDA: 020883

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NDA 020883 describes ARGATROBAN, which is a drug marketed by Fresenius Kabi Usa, Hikma Pharm Co Ltd, Mylan Institutional, Par Sterile Products, Teva Pharms Usa, Sandoz, and Eagle Pharms, and is included in one NDA. It is available from two 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 ten drug master file entries for this compound. Six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the argatroban profile page.

Summary for NDA: 020883

Tradename:
ARGATROBAN
Applicant:
Pfizer
Ingredient:
argatroban
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020883

Mechanism of ActionThrombin Inhibitors

Suppliers and Packaging for NDA: 020883

Tradename Generic Name Dosage NDA Supplier National Drug Code Package Code Package
ACOVA
argatroban
INJECTABLE;INJECTION 020883 GlaxoSmithKline LLC 0007-4407 0007-4407-01 1 VIAL in 1 CARTON (0007-4407-01) > 2.5 mL in 1 VIAL
ACOVA
argatroban
INJECTABLE;INJECTION 020883 GlaxoSmithKline LLC 0007-4407 0007-4407-54 1 VIAL in 1 CARTON (0007-4407-54) > 2.5 mL in 1 VIAL
Glossary

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE; INJECTIONStrength100MG/ML
Approval Date:Jun 30, 2000TE:RLD:Yes
Patent:5,214,052Patent Expiration:Jun 30, 2014Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:May 5, 2011
Regulatory Exclusivity Use:PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS (HITTS)


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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