APPLICATION
ANDA216568
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-30
LATEST ACTION
2024-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NEBIVOLOL HYDROCHLORIDEPrescription
NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
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
Approval history
2024-08-08Manufacturing (CMC) · Supplement 3 · unknownAP
2023-03-30UNKNOWN · Original · 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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