← FDA Drug Approvals (Drugs@FDA)
OPSUMIT
NDA · New Drug Application · Sponsor: ACTELION · Approved 2013-10-18
Drug application
- FDA Application #
NDA204410- Application type
- New Drug Application
- Brand name
- OPSUMIT
- Generic name
- MACITENTAN
- Active ingredients
- MACITENTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ACTELION
- Manufacturer
- Actelion Pharmaceuticals US, Inc.
- First approval
- 2013-10-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown