Drug application

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

Drugs@FDA ANDA 206661 · APOZEAL PHARMS

Key facts

Drug name HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Active ingredients HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Application type ANDA
Application number 206661
Company APOZEAL PHARMS
Dosage forms SOLUTION, ORAL
Strength 5MG/5ML;60MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jan 23, 2019

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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