Sphingosine-1-phosphate (S1P) receptor modulators
Fingolimod
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- FINGOLIMOD 0.5MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FINGOLIMOD 0.5MG · CapsuleThis page
- FINGOLIMOD EQ 0.5MG BASE · CapsuleANDA207940-001 · Tentative approval
- FINGOLIMOD 0.5MG · CapsuleANDA208559-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA207965.
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
- Fingolimod
- Drug class
- Sphingosine-1-phosphate (S1P) receptor modulators
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Par Pharm Inc
- Status
- Tentative approval
- FDA approval
- 22 Mar 2017
- Application
- ANDA207965-001
- RxCUI
- 1012892