Composition
- Active ingredients
- FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE · CapsuleThis page
- FINGOLIMOD HYDROCHLORIDE EQ 0.25MG BASE · CapsuleNDA022527-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA022527.
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
- Gilenya
- Active substance
- fingolimod hydrochloride
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Novartis
- Status
- Prescription
- FDA approval
- 21 Sept 2010
- Application
- NDA022527-001