General MedicationsORALStandard
VYDUO
NEBIVOLOL HYDROCHLORIDE; VALSARTAN
Standard Dose
EQ 5MG BASE;80MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview VYDUO is listed in Drugs@FDA under application 210596 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient NEBIVOLOL HYDROCHLORIDE; VALSARTAN Form and strength TABLET;ORAL - EQ 5MG BASE;80MG Sponsor PRINSTON INC Submission history Latest submission status date: 2022-09-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview VYDUO is listed in Drugs@FDA under application 210596 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NEBIVOLOL HYDROCHLORIDE; VALSARTAN Form and strength TABLET;ORAL - EQ 5MG BASE;80MG Sponsor PRINSTON INC Submission history Latest submission status date: 2022-09-19 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.