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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211996

VYNDAQEL (TAFAMIDIS MEGLUMINE)
20MG
Marketing Status: Prescription
Active Ingredient: TAFAMIDIS MEGLUMINE
Proprietary Name: VYNDAQEL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211996
Product Number: 001
Approval Date: May 3, 2019
Applicant Holder Full Name: FOLDRX PHARMACEUTICALS LLC A WHOLLY OWNED SUB OF PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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