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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208470

INTRAROSA (PRASTERONE)
6.5MG
Marketing Status: Prescription
Active Ingredient: PRASTERONE
Proprietary Name: INTRAROSA
Dosage Form; Route of Administration: INSERT; VAGINAL
Strength: 6.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208470
Product Number: 001
Approval Date: Nov 16, 2016
Applicant Holder Full Name: MILLICENT PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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