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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202860

Marketing Status: Prescription
Active Ingredient: NITRIC OXIDE
Proprietary Name: GENOSYL
Dosage Form; Route of Administration: GAS; INHALATION
Strength: 800PPM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202860
Product Number: 001
Approval Date: Dec 20, 2019
Applicant Holder Full Name: VERO BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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