General MedicationsORALStandard

DULOXETINE HYDROCHLORIDE

Standard Dose

EQ 80MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DULOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 219131 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DULOXETINE HYDROCHLORIDE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 80MG BASE Sponsor ALMATICA Submission history Latest submission status date: 2026-02-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview DULOXETINE HYDROCHLORIDE is listed in Drugs@FDA under application 219131 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DULOXETINE HYDROCHLORIDE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 80MG BASE Sponsor ALMATICA Submission history Latest submission status date: 2026-02-27 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.