Orange Book product

BIVALIRUDIN 250MG/VIAL

Orange Book ANDA 090816 · HOSPIRA INC · Discontinued

Key facts

Proprietary name BIVALIRUDIN
Active ingredients BIVALIRUDIN
Strength 250MG/VIAL
Dosage form INJECTABLE
Route INTRAVENOUS
Application ANDA090816
Applicant holder HOSPIRA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 14, 2015

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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