Home Applications 216568 Application 216568
Type ANDA
Sponsor REGCON HOLDINGS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 2.5MG BASE No No 002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 5MG BASE No No 003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No 004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE TABLET;ORAL EQ 20MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216568-001 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 A216568-002 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 A216568-003 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 A216568-004 NEBIVOLOL HYDROCHLORIDE NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 3 · 92 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216568-001 NEBIVOLOL HYDROCHLORIDE EQ 2.5MG BASE TABLET / ORAL AB 2023-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216568-002 NEBIVOLOL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2023-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216568-003 NEBIVOLOL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2023-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216568-004 NEBIVOLOL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2023-03-30 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join nebivolol NEBIVOLOL HYDROCHLORIDE Apnar Pharma LP 3f5766c0-e1fa-4805-a32c-523182310ad5 2025-02-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216568 application number: ANDA216568