Composition
- Active ingredients
- VORTIOXETINE 15MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- VORTIOXETINE 15MG · TabletANDA211024-003 · Tentative approval
- VORTIOXETINE 5MG · TabletANDA211024-001 · Tentative approval
- VORTIOXETINE 20MG · TabletANDA211024-004 · Tentative approval
- VORTIOXETINE 10MG · TabletANDA211024-002 · Tentative approval
- VORTIOXETINE 5MG · TabletANDA211085-001 · Tentative approval
- VORTIOXETINE 10MG · TabletANDA211089-002 · Tentative approval
- VORTIOXETINE 15MG · TabletThis page
- VORTIOXETINE 5MG · TabletANDA211089-001 · Tentative approval
- VORTIOXETINE 20MG · TabletANDA211089-004 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA211089.
At a glance
- Brand name
- Vortioxetine
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Alkem Labs LTD
- Status
- Tentative approval
- FDA approval
- 21 Aug 2019
- Application
- ANDA211089-003