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.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
Alkem Labs Ltd | vortioxetine | 211089 | 5MG | TABLET;ORAL |
Prinston Pharma Inc | vortioxetine | 211024 | 10MG | TABLET;ORAL |
Alkem Labs Ltd | vortioxetine | 211089 | 20MG | TABLET;ORAL |
Prinston Pharma Inc | vortioxetine | 211024 | 15MG | TABLET;ORAL |
Zydus Pharms | vortioxetine hydrobromide | 211146 | EQ 10MG BASE | TABLET;ORAL |
Zydus Pharms | vortioxetine hydrobromide | 211146 | EQ 5MG BASE | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |