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FDA ANDA · ANDA211165

VORTIOXETINE HYDROBROMIDE

Sponsor: MACLEODS PHARMACEUTICALS LTD

APPLICATION
ANDA211165
TYPE
ANDA
DOSAGE FORM
TABLET:FILM COATED
MARKETING STATUS
None (Tentative Approval)

Products

VORTIOXETINE HYDROBROMIDENone (Tentative Approval)
VORTIOXETINE 15MG · TABLET:FILM COATED
VORTIOXETINE HYDROBROMIDENone (Tentative Approval)
VORTIOXETINE 20MG · TABLET:FILM COATED
VORTIOXETINE HYDROBROMIDENone (Tentative Approval)
VORTIOXETINE 5MG · TABLET:FILM COATED
VORTIOXETINE HYDROBROMIDENone (Tentative Approval)
VORTIOXETINE 10MG · TABLET:FILM COATED

Approval history

2025-11-10UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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