Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210797

SCENESSE (AFAMELANOTIDE)
16MG
Marketing Status: Prescription
Active Ingredient: AFAMELANOTIDE
Proprietary Name: SCENESSE
Dosage Form; Route of Administration: IMPLANT; SUBCUTANEOUS
Strength: 16MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210797
Product Number: 001
Approval Date: Oct 8, 2019
Applicant Holder Full Name: CLINUVEL INC
Marketing Status:  Prescription
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