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General MedicationsORALGeneric

SARAFEM

FLUOXETINE HYDROCHLORIDE

Standard Dose
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview SARAFEM is listed in Drugs@FDA under application 021860 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor APIL Submission history Latest submission status date: 2021-09-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview SARAFEM is listed in Drugs@FDA under application 021860 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor APIL Submission history Latest submission status date: 2021-09-20 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.