Orange Book product

OXYCODONE AND ASPIRIN (HALF-STRENGTH) 325MG;2.25MG;0.19MG

Orange Book ANDA 087742 · ROXANE LABORATORIES INC · Discontinued

Key facts

Proprietary name OXYCODONE AND ASPIRIN (HALF-STRENGTH)
Active ingredients ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE
Strength 325MG;2.25MG;0.19MG
Dosage form TABLET
Route ORAL
Application ANDA087742
Applicant holder ROXANE LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 4, 1982

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