Orange Book product

DARVOCET A500 500MG;100MG

Orange Book ANDA 076429 · XANODYNE PHARMACEUTICS INC · Discontinued

Key facts

Proprietary name DARVOCET A500
Active ingredients ACETAMINOPHEN, PROPOXYPHENE NAPSYLATE
Strength 500MG;100MG
Dosage form TABLET
Route ORAL
Application ANDA076429
Applicant holder XANODYNE PHARMACEUTICS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 10, 2003

At a glance

  • None 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)

Browse all Orange Book products