Drug application

HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)

Drugs@FDA ANDA 205814 · AUROLIFE PHARMA LLC

Key facts

Drug name HYDROMORPHONE HYDROCHLORIDE
Active ingredients HYDROMORPHONE HYDROCHLORIDE
Application type ANDA
Application number 205814
Company AUROLIFE PHARMA LLC
Dosage forms TABLET, ORAL
Strength 2MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date May 13, 2016

At a glance

  • 1–9 Submissions
  • 1–9 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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