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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217389

OHTUVAYRE (ENSIFENTRINE)
3MG/2.5ML
Marketing Status: Prescription
Active Ingredient: ENSIFENTRINE
Proprietary Name: OHTUVAYRE
Dosage Form; Route of Administration: SUSPENSION; INHALATION
Strength: 3MG/2.5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217389
Product Number: 001
Approval Date: Jun 26, 2024
Applicant Holder Full Name: VERONA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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