Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213978

TYRVAYA (VARENICLINE TARTRATE)
EQ 0.03MG BASE/SPRAY
Marketing Status: Prescription
Active Ingredient: VARENICLINE TARTRATE
Proprietary Name: TYRVAYA
Dosage Form; Route of Administration: SOLUTION; NASAL
Strength: EQ 0.03MG BASE/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213978
Product Number: 001
Approval Date: Oct 15, 2021
Applicant Holder Full Name: OYSTER POINT PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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