Composition
- Active ingredients
- BALOXAVIR MARBOXIL 40MG/PACKET
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BALOXAVIR MARBOXIL 30MG/PACKET · For suspensionNDA214410-002 · Prescription
- BALOXAVIR MARBOXIL 40MG/PACKET · For suspensionThis page
- BALOXAVIR MARBOXIL 2MG/ML · For suspensionNDA214410-001 · Prescription
- BALOXAVIR MARBOXIL 40MG · TabletNDA210854-002 · Prescription
- BALOXAVIR MARBOXIL 80MG · TabletNDA210854-003 · Prescription
- BALOXAVIR MARBOXIL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA210854-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA214410.
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
- Xofluza
- Active substance
- baloxavir marboxil
- Route
- Oral
- Dosage form
- For suspension
- Applicant
- Genentech Inc
- Status
- Prescription
- FDA approval
- 11 Aug 2022
- Application
- NDA214410-003