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FDA ANDA · ANDA213830

NEBIVOLOL HYDROCHLORIDE

Sponsor: UNICHEM

APPLICATION
ANDA213830
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-15
LATEST ACTION
2023-08-25
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

2023-08-25Labeling · Supplement 4 · standardAP
2022-03-15UNKNOWN · Original · standardAP
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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