Sphingosine-1-phosphate (S1P) receptor modulators
Ozanimod
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- OZANIMOD 0.46MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- OZANIMOD 0.23MG · CapsuleANDA219236-003 · Tentative approval
- OZANIMOD 0.46MG · CapsuleThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA219236.
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
- Ozanimod
- Drug class
- Sphingosine-1-phosphate (S1P) receptor modulators
- Dosage form
- Capsule
- Applicant
- Synthon BV
- Status
- Tentative approval
- FDA approval
- 22 Jul 2025
- Application
- ANDA219236-002
- RxCUI
- 2288236