FDA.reportPublic FDA data

Application 203683

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 2.5MG BASENoNo
002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 5MG BASENoNo
003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203683-001NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORAL2015-11-27
A203683-002NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2015-11-27
A203683-003NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27
A203683-004NEBIVOLOL HYDROCHLORIDENEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203683-001NEBIVOLOL HYDROCHLORIDEEQ 2.5MG BASETABLET / ORAL2015-11-27a50c72e98297…
2026-08-01 22:54:322026-06A203683-002NEBIVOLOL HYDROCHLORIDEEQ 5MG BASETABLET / ORAL2015-11-27a50c72e98297…
2026-08-01 22:54:322026-06A203683-003NEBIVOLOL HYDROCHLORIDEEQ 10MG BASETABLET / ORAL2015-11-27a50c72e98297…
2026-08-01 22:54:322026-06A203683-004NEBIVOLOL HYDROCHLORIDEEQ 20MG BASETABLET / ORAL2015-11-27a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10244ORIG2015-12-01