← FDA DRUG APPROVALS

FDA NDA · NDA210797

SCENESSE

afamelanotide

Sponsor: CLIVUNEL INC

APPLICATION
NDA210797
TYPE
NDA
ORIGINAL APPROVAL
2019-10-08
LATEST ACTION
2024-08-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

SCENESSE · ReferencePrescription
AFAMELANOTIDE 16MG · IMPLANT · SUBCUTANEOUS

Approval history

2024-08-12Labeling · Supplement 7 · standard — Label ↗AP
2019-10-08Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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