Drug application

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

Drugs@FDA ANDA 204627 · PADAGIS US

Key facts

Drug name HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Active ingredients CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Application type ANDA
Application number 204627
Company PADAGIS US
Dosage forms SOLUTION, ORAL
Strength 4MG/5ML;5MG/5ML;60MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Apr 29, 2014

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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