Details for New Drug Application (NDA): 020883

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NDA 020883 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 020883

Tradename:	ARGATROBAN
Applicant:	Sandoz
Ingredient:	argatroban
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	250MG/2.5ML (100MG/ML)
Approval Date:	Jun 30, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 020883

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	⤷ Sign Up	⤷ Sign Up
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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