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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 020873


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NDA 020873 describes ANGIOMAX, which is a drug marketed by Sandoz Inc 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 Inc
Ingredient:bivalirudin
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 020873
Mechanism of ActionThrombin 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
Paragraph IV (Patent) Challenges for 020873
Tradename Dosage Ingredient NDA Submissiondate
ANGIOMAX INJECTABLE;INTRAVENOUS bivalirudin 020873 2009-09-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/VIAL
Approval Date:Dec 15, 2000TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 27, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jan 27, 2029Product Flag?Substance Flag?Delist Request?Y

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