Details for New Drug Application (NDA): 203049

NDA 203049 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, 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

Pharmacology for NDA: 203049

Mechanism of Action

Thrombin 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	250MG/2.5ML (100MG/ML)
Approval Date:	Jan 5, 2012	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/50ML (1MG/ML)
Approval Date:	Sep 30, 2016	TE:	AP	RLD:	Yes

Complete Access Available with Subscription