← FDA Drug Approvals (Drugs@FDA)
MACITENTAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2025-12-03
Drug application
- FDA Application #
ANDA211161- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MACITENTAN
- Generic name
- Macitentan
- Active ingredients
- MACITENTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MYLAN
- First approval
- 2025-12-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown