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General MedicationsORALStandard

DRIZALMA SPRINKLE

DULOXETINE HYDROCHLORIDE

Standard Dose
EQ 30MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DRIZALMA SPRINKLE is listed in Drugs@FDA under application 212516 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DULOXETINE HYDROCHLORIDE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE Sponsor SUN PHARM Submission history Latest submission status date: 2023-08-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview DRIZALMA SPRINKLE is listed in Drugs@FDA under application 212516 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DULOXETINE HYDROCHLORIDE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - EQ 30MG BASE Sponsor SUN PHARM 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.