← FDA Drug Approvals (Drugs@FDA)
SCENESSE
NDA · New Drug Application · Sponsor: CLIVUNEL INC · Approved 2019-10-08
Drug application
- FDA Application #
NDA210797- Application type
- New Drug Application
- Brand name
- SCENESSE
- Generic name
- AFAMELANOTIDE
- Active ingredients
- AFAMELANOTIDE
- Dosage form
- IMPLANT
- Route
- SUBCUTANEOUS
- Marketing status
- Prescription
- Sponsor
- CLIVUNEL INC
- Manufacturer
- CLINUVEL INC.
- First approval
- 2019-10-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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