Application 212661
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212661-001 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | |
| A212661-002 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | |
| A212661-003 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | |
| A212661-004 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212661-001 | AB |
| A212661-002 | AB |
| A212661-003 | AB |
| A212661-004 | AB |
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 | 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 | A212661-001 | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212661-002 | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212661-003 | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212661-004 | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-001 | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-002 | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-003 | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-004 | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-001 | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-002 | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-003 | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-004 | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-001 | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-002 | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-003 | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-004 | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-001 | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-002 | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-003 | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-004 | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 | b8a1b40f171c… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-001 | NEBIVOLOL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET / ORAL | AB | 2025-01-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-002 | NEBIVOLOL HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2025-01-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-003 | NEBIVOLOL HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2025-01-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-004 | NEBIVOLOL HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2025-01-28 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212661-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212661-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212661-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212661-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212661-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212661-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212661-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212661-004 | AB | 1 | b8a1b40f171c… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212661-004 | AB | 1 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nebivolol | NEBIVOLOL | NorthStar RxLLC | 9a81733f-abb2-4090-a1e1-cbca356821e8 | 2025-07-01 | Warnings, Adverse reactions | 212661 ANDA212661 |
| Nebivolol | NEBIVOLOL | Macleods Pharmaceuticals Limited | b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e | 2025-04-08 | Warnings, Adverse reactions | 212661 ANDA212661 |