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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203049


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NDA 203049 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Par Sterile Products, Sandoz, Teva Pharms Usa, Cipla, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen NDAs. It is available from nine 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 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 203049
Tradename:ARGATROBAN
Applicant:Hikma Pharm Co Ltd
Ingredient:argatroban
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203049
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 203049
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN argatroban INJECTABLE;INJECTION 203049 NDA Hikma Pharmaceuticals USA Inc. 0143-9288 0143-9288-01 1 VIAL in 1 CARTON (0143-9288-01) / 2.5 mL in 1 VIAL
ARGATROBAN argatroban INJECTABLE;INJECTION 203049 NDA Hikma Pharmaceuticals USA Inc. 0143-9377 0143-9377-01 1 VIAL in 1 CARTON (0143-9377-01) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Jan 5, 2012TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/50ML (1MG/ML)
Approval Date:Sep 30, 2016TE:APRLD:Yes

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