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FDA NDA · NDA206302

BYVALSON

Sponsor: ABBVIE

APPLICATION
NDA206302
TYPE
NDA
ORIGINAL APPROVAL
2016-06-03
LATEST ACTION
2023-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BYVALSON · ReferenceDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE, VALSARTAN 80MG · TABLET · ORAL

Approval history

2023-06-16Labeling · Supplement 1 · standard — Letter ↗AP
2016-06-03Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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