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General MedicationsORALStandard

FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE

Standard Dose
EQ 20MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary

Approval overview FLUOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 213286 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2026-01-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLUOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 213286 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2026-01-15 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: UNKNOWN

Interaction Notes

  • No interaction notes stored yet.