FDA
Vortioxetine Hydrobromide
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- VORTIOXETINE HYDROBROMIDE 20MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- VORTIOXETINE HYDROBROMIDE 5MG · TabletANDA211130-004 · Tentative approval
- VORTIOXETINE HYDROBROMIDE 10MG · TabletANDA211130-002 · Tentative approval
- VORTIOXETINE HYDROBROMIDE 15MG · TabletANDA211130-003 · Tentative approval
- VORTIOXETINE HYDROBROMIDE EQ 20MG BASE · TabletANDA211146-003 · Discontinued
- VORTIOXETINE HYDROBROMIDE EQ 5MG BASE · TabletANDA211146-001 · Discontinued
- VORTIOXETINE HYDROBROMIDE EQ 10MG BASE · TabletANDA211146-002 · Discontinued
- VORTIOXETINE HYDROBROMIDE 20MG · TabletThis page
- VORTIOXETINE HYDROBROMIDE 10MG · TabletANDA211101-002 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA211101.
At a glance
- Brand name
- Vortioxetine Hydrobromide
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- MSN Laboratories Private LTD
- Status
- Tentative approval
- FDA approval
- 3 Nov 2025
- Application
- ANDA211101-003