General MedicationsORALStandard

FLUOXETINE HYDROCHLORIDE

Standard Dose

EQ 90MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview FLUOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 078572 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE Sponsor DR REDDYS LABS LTD Submission history Latest submission status date: 2023-08-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLUOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 078572 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUOXETINE HYDROCHLORIDE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE Sponsor DR REDDYS LABS LTD Submission history Latest submission status date: 2023-08-18 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.