Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205598

MACRILEN (MACIMORELIN ACETATE)
EQ 60MG BASE/POUCH
Marketing Status: Prescription
Active Ingredient: MACIMORELIN ACETATE
Proprietary Name: MACRILEN
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 60MG BASE/POUCH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205598
Product Number: 001
Approval Date: Dec 20, 2017
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
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