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Last Updated: October 1, 2023

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 two suppliers. There are two 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. Fourteen 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020873

Mechanism of Action	Thrombin Inhibitors

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	Sandoz Inc	0781-3158	0781-3158-95	10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94)
ANGIOMAX	bivalirudin	INJECTABLE;INTRAVENOUS	020873	NDA	Sandoz Inc	0781-3447	0781-3447-95	10 VIAL, SINGLE-USE in 1 CARTON (0781-3447-95) / 1 INJECTION in 1 VIAL, SINGLE-USE

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:	⤷ Try a Trial	Patent Expiration:	Jan 27, 2029	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Try a Trial	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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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