Orange Book product

OXYCODONE AND ASPIRIN 325MG;4.5MG;0.38MG

Orange Book ANDA 040260 · SUN PHARMACEUTICAL INDUSTRIES INC · Discontinued

Key facts

Proprietary name OXYCODONE AND ASPIRIN
Active ingredients ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE
Strength 325MG;4.5MG;0.38MG
Dosage form TABLET
Route ORAL
Application ANDA040260
Applicant holder SUN PHARMACEUTICAL INDUSTRIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jul 17, 1998

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)

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