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General MedicationsORALGeneric

APADAZ

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

Standard Dose
325MG;EQ 8.16MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Discontinued
Summary

Approval overview APADAZ is listed in Drugs@FDA under application 208653 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 325MG;EQ 8.16MG BASE Sponsor ZEVRA THERAP Submission history Latest submission status date: 2024-10-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview APADAZ is listed in Drugs@FDA under application 208653 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE Form and strength TABLET;ORAL - 325MG;EQ 8.16MG BASE Sponsor ZEVRA THERAP Submission history Latest submission status date: 2024-10-31 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.
APADAZ (ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE) | Drug Monograph | MedicHelpline