Drug application

OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)

Drugs@FDA ANDA 201187 · EPIC PHARMA LLC

Key facts

Drug name OXYMORPHONE HYDROCHLORIDE
Active ingredients OXYMORPHONE HYDROCHLORIDE
Application type ANDA
Application number 201187
Company EPIC PHARMA LLC
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Dec 15, 2014

At a glance

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