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General MedicationsORALStandard

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Standard Dose
EQ 50MG BASE;EQ 6MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OLANZAPINE AND FLUOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 078901 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOXETINE HYDROCHLORIDE; OLANZAPINE Form and strength CAPSULE;ORAL - EQ 50MG BASE;EQ 6MG BASE Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2026-02-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview OLANZAPINE AND FLUOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 078901 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOXETINE HYDROCHLORIDE; OLANZAPINE Form and strength CAPSULE;ORAL - EQ 50MG BASE;EQ 6MG BASE Sponsor EPIC PHARMA LLC Submission history Latest submission status date: 2026-02-06 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.