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General MedicationsORALGeneric

TREZIX

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Standard Dose
320.5MG;30MG;16MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview TREZIX is listed in Drugs@FDA under application 204785 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE Form and strength CAPSULE;ORAL - 320.5MG;30MG;16MG Sponsor KEY THERAP Submission history Latest submission status date: 2023-12-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview TREZIX is listed in Drugs@FDA under application 204785 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE Form and strength CAPSULE;ORAL - 320.5MG;30MG;16MG Sponsor KEY THERAP Submission history Latest submission status date: 2023-12-15 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.