Orange Book product

ANGIOMAX 250MG/VIAL

Orange Book NDA 020873 · SANDOZ INC · Prescription

Key facts

Proprietary name ANGIOMAX
Active ingredients BIVALIRUDIN
Strength 250MG/VIAL
Dosage form INJECTABLE
Route INTRAVENOUS
Application NDA020873
Applicant holder SANDOZ INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Dec 15, 2000

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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