APPLICATION
ANDA203683
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-27
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEDiscontinued
NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2025-08-01Labeling · Supplement 1 · standardAP
2025-08-01Labeling · Supplement 4 · standardAP
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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