Orange Book product

VELETRI EQ 0.5MG BASE/VIAL

Orange Book NDA 022260 · ACTELION PHARMACEUTICALS US INC · Prescription

Key facts

Proprietary name VELETRI
Active ingredients EPOPROSTENOL SODIUM
Strength EQ 0.5MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application NDA022260
Applicant holder ACTELION PHARMACEUTICALS US INC
Marketing status Prescription
Therapeutic equivalence (TE) code AP2
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jun 28, 2012

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)

Browse all Orange Book products