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FDA Approval

SCENESSE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
CLINUVEL INC.
DUNS: 937954977
Effective Date
October 16, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Afamelanotide(16 mg in 16 mg)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SCENESSE

Product Details

NDC Product Code
73372-0116
Application Number
NDA210797
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
October 16, 2023
Code: QW68W3J66UClass: ACTIBQuantity: 16 mg in 16 mg
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