Last Updated: July 18, 2026

Generic Companies with Tentative Approvals for: vortioxetine

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vortioxetine Generic Filers with Tentative Approvals

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Macleods Pharmaceuticals Ltd	vortioxetine	211165	20MG	TABLET:FILM COATED
Macleods Pharmaceuticals Ltd	vortioxetine	211165	10MG	TABLET:FILM COATED
Prinston Pharma Inc	vortioxetine	211024	15MG	TABLET;ORAL
Prinston Pharma Inc	vortioxetine	211024	10MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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