Drug application

OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)

Drugs@FDA ANDA 200822 · HIKMA PHARMS

Key facts

Drug name OXYMORPHONE HYDROCHLORIDE
Active ingredients OXYMORPHONE HYDROCHLORIDE
Application type ANDA
Application number 200822
Company HIKMA PHARMS
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 40MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Jul 15, 2013

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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