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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210596

VYDUO (NEBIVOLOL HYDROCHLORIDE; VALSARTAN)
EQ 5MG BASE;80MG
Marketing Status: Prescription
Active Ingredient: NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Proprietary Name: VYDUO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A210596
Product Number: 001
Approval Date: Sep 19, 2022
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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