APPLICATION
ANDA203828
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-29
LATEST ACTION
2024-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NEBIVOLOL HYDROCHLORIDEPrescription
NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEPrescription
NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEPrescription
NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
NEBIVOLOL HYDROCHLORIDEPrescription
NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
Approval history
2024-08-27Labeling · Supplement 10 · standardAP
2023-08-25Labeling · Supplement 9 · standardAP
2021-11-19Labeling · Supplement 3 · standardAP
2015-07-29UNKNOWN · OriginalAP
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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