FDA.reportPublic FDA data

Application 206729

Type
ANDA
Sponsor
MICRO LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORAL2.5MGNoNo
002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORAL5MGNoNo
003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo
004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nebivololNEBIVOLOL HYDROCHLORIDEAvKARE1ce89dc5-018d-db40-e063-6294a90a97222026-01-16Warnings, Adverse reactionsName fallback
generic name: NEBIVOLOL HYDROCHLORIDE
nebivololNEBIVOLOL HYDROCHLORIDEApnar Pharma LP3f5766c0-e1fa-4805-a32c-523182310ad52025-02-14Warnings, Adverse reactionsName fallback
generic name: NEBIVOLOL HYDROCHLORIDE
BystolicNEBIVOLOL HYDROCHLORIDEAllergan, Inc.8b8ad213-1dc8-454e-a524-075685c0e1a82024-08-01Warnings, Adverse reactionsName fallback
generic name: NEBIVOLOL HYDROCHLORIDE
nebivololNEBIVOLOL HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USAcb47560d-9e35-4b0f-b12b-6ea478684a5b2023-08-01Warnings, Adverse reactionsName fallback
generic name: NEBIVOLOL HYDROCHLORIDE
Nebivolol HydrochlorideNEBIVOLOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.b1762bbb-b5be-48a7-8101-bb736f28845a2023-07-11Warnings, Adverse reactionsName fallback
brand name: Nebivolol Hydrochloride
generic name: NEBIVOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.