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General MedicationsTABLET:FILM COATEDGeneric

VORTIOXETINE HYDROBROMIDE

VORTIOXETINE

Standard Dose
5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview VORTIOXETINE HYDROBROMIDE is listed in Drugs@FDA under application 211165 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient VORTIOXETINE Form and strength TABLET:FILM COATED - 5MG Sponsor MACLEODS PHARMACEUTICALS LTD Submission history Latest submission status date: 2025-11-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview VORTIOXETINE HYDROBROMIDE is listed in Drugs@FDA under application 211165 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient VORTIOXETINE Form and strength TABLET:FILM COATED - 5MG Sponsor MACLEODS PHARMACEUTICALS LTD Submission history Latest submission status date: 2025-11-10 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.