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Details for New Drug Application (NDA): 020883

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NDA 020883 describes ARGATROBAN, which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Hikma Pharm Co Ltd, Par Sterile Products, Pfizer, Teva Pharms Usa, Sandoz, and Eagle Pharms, and is included in nine NDAs. It is available from four 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. Seven 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:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020883

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Jun 30, 2000TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020883

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ARGATROBAN
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 20005,214,052<disabled>
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