Drug application

OXYCODONE AND ASPIRIN (ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE)

Drugs@FDA ANDA 040255 · ANI PHARMS

Key facts

Drug name OXYCODONE AND ASPIRIN
Active ingredients ASPIRIN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE
Application type ANDA
Application number 040255
Company ANI PHARMS
Dosage forms TABLET, ORAL
Strength 325MG;4.5MG;0.38MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Feb 27, 1998

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • No FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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