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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213793

IMCIVREE (SETMELANOTIDE ACETATE)
EQ 10MG BASE/ML (EQ 10MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: SETMELANOTIDE ACETATE
Proprietary Name: IMCIVREE
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 10MG BASE/ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213793
Product Number: 001
Approval Date: Nov 25, 2020
Applicant Holder Full Name: RHYTHM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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