Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022526

ADDYI (FLIBANSERIN)
100MG Marketing Status: Prescription

Active Ingredient: FLIBANSERIN
Proprietary Name: ADDYI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022526
Product Number: 001
Approval Date: Aug 18, 2015
Applicant Holder Full Name: SPROUT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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