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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210598

Marketing Status: Prescription
Active Ingredient: REVEFENACIN
Proprietary Name: YUPELRI
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 175MCG/3ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210598
Product Number: 001
Approval Date: Nov 9, 2018
Applicant Holder Full Name: MYLAN IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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