Drug application

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE)

Drugs@FDA ANDA 204765 · APOZEAL PHARMS

Key facts

Drug name HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Active ingredients HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATE
Application type ANDA
Application number 204765
Company APOZEAL PHARMS
Dosage forms SYRUP, ORAL
Strength 1.5MG/5ML;5MG/5ML
Marketing status Discontinued
Reference listed drug No
Latest submission status date Mar 6, 2017

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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