Composition
- Active ingredients
- MACITENTAN 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- MACITENTAN 10MG · TabletANDA211026-001 · Prescription
- MACITENTAN 10MG · TabletANDA211123-001 · Prescription
- MACITENTAN 10MG · TabletANDA211161-001 · Prescription
- MACITENTAN 10MG · TabletANDA214112-001 · Tentative approval
- MACITENTAN 10MG · TabletANDA211136-001 · Prescription
- MACITENTAN 10MG · TabletThis page
- MACITENTAN 10MG · TabletANDA211195-001 · Prescription
- MACITENTAN 10MG · TabletANDA211224-001 · Prescription
- MACITENTAN 10MG · TabletANDA211128-001 · Prescription
- MACITENTAN 10MG · TabletANDA211107-001 · Prescription
- MACITENTAN 10MG · TabletANDA211198-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA211120.
At a glance
- Brand name
- Macitentan
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Laurus
- Status
- Prescription
- FDA approval
- 5 Nov 2025
- Application
- ANDA211120-001