Drug application

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE)

Drugs@FDA ANDA 203839 · TRIS PHARMA INC

Key facts

Drug name HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Active ingredients HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Application type ANDA
Application number 203839
Company TRIS PHARMA INC
Dosage forms SOLUTION, ORAL
Strength 5MG/5ML;60MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Oct 28, 2014

At a glance

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

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

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