FDA
Vortioxetine Hydrobromide
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- VORTIOXETINE 15MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA211165.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Vortioxetine Hydrobromide
- Active substance
- vortioxetine
- Dosage form
- Tablet:film coated
- Applicant
- Macleods Pharmaceuticals LTD
- Status
- Tentative approval
- FDA approval
- 10 Nov 2025
- Application
- ANDA211165-003