Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208743

3.12MG/1.56ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ABALOPARATIDE
Proprietary Name: TYMLOS
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 3.12MG/1.56ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208743
Product Number: 001
Approval Date: Apr 28, 2017
Applicant Holder Full Name: RADIUS HEALTH INC
Marketing Status:  Prescription
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