← FDA DRUG APPROVALS

FDA NDA · NDA021742

BYSTOLIC

nebivolol hydrochloride

Sponsor: ALLERGAN

APPLICATION
NDA021742
TYPE
NDA
ORIGINAL APPROVAL
2007-12-17
LATEST ACTION
2023-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BYSTOLIC · ReferencePrescription
NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
BYSTOLIC · ReferencePrescription
NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
BYSTOLIC · ReferencePrescription
NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE · TABLET · ORAL
BYSTOLIC · ReferencePrescription
NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2023-06-16Labeling · Supplement 28 · standard — Letter ↗AP
2017-11-30Labeling · Supplement 22 · standard — Label ↗AP
2015-04-20Manufacturing (CMC) · Supplement 20 · standardAP
2014-10-30Manufacturing (CMC) · Supplement 18 · standardAP
2014-10-27Manufacturing (CMC) · Supplement 19 · standardAP
2013-09-20Manufacturing (CMC) · Supplement 17 · standardAP
2012-12-19Manufacturing (CMC) · Supplement 16 · standardAP
2011-12-14Labeling · Supplement 13 · unknown — Label ↗AP
2010-02-19Efficacy · Supplement 7 · standard — Letter ↗AP
2008-10-08Manufacturing (CMC) · Supplement 3AP
2007-12-17Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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