Drug Approval Package
Angiomax
(Bivalirudin) Injection
Company: The Medicines Company
Application No.: 20-873
Approval Date: 12/15/2000
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Approval Letter(s)(PDF)
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Printed Labeling(PDF)
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Chemistry Review(s)(PDF)
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Pharmacology Review(s)
Part 1(PDF)
Part 2(PDF)
Part 3(PDF)
Part 4(PDF) -
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1(PDF)
Part 2(PDF)
Part 3(PDF) -
Correspondence(PDF)
Date created: November 20, 2001
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