Details for New Drug Application (NDA): 020873

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NDA 020873 describes ANGIOMAX, which is a drug marketed by Sandoz and Maia Pharms Inc and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ANGIOMAX profile page.

The generic ingredient in ANGIOMAX is bivalirudin. There are fourteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

Summary for 020873

Tradename:	ANGIOMAX
Applicant:	Sandoz
Ingredient:	bivalirudin
Patents:	2

Suppliers and Packaging for NDA: 020873

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873	NDA AUTHORIZED GENERIC	Civica, Inc.	72572-035	72572-035-10	10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	Dec 15, 2000	TE:	AP	RLD:	Yes
Patent:	7,582,727*PED	Patent Expiration:	Jan 27, 2029	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	7,598,343*PED	Patent Expiration:	Jan 27, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020873

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873-001	Dec 15, 2000	5,196,404*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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