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VORTIOXETINE HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2026-01-29

Drug application

FDA Application #

ANDA211130

Application type

Abbreviated New Drug Application (Generic)

Brand name

VORTIOXETINE HYDROBROMIDE

Generic name

Vortioxetine Hydrobromide

Active ingredients

VORTIOXETINE HYDROBROMIDE

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

APOTEX INC

First approval

2026-01-29

Source

Authoritative

Drugs@FDA application overview

Machine

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