Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203505

Marketing Status: Prescription
Active Ingredient: OSPEMIFENE
Proprietary Name: OSPHENA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203505
Product Number: 001
Approval Date: Feb 26, 2013
Applicant Holder Full Name: DUCHESNAY INC
Marketing Status:  Prescription
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