Drug application

PALLADONE (HYDROMORPHONE HYDROCHLORIDE)

Drugs@FDA NDA 021044 · PURDUE PHARMA LP

Key facts

Drug name PALLADONE
Active ingredients HYDROMORPHONE HYDROCHLORIDE
Application type NDA
Application number 021044
Company PURDUE PHARMA LP
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 12MG
Marketing status Discontinued
Reference listed drug No
Latest submission class Type 3 - New Dosage Form
Latest submission status date Sep 24, 2004

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes 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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