Application 018917
- Type
- NDA
- Sponsor
- PROMIUS PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | Yes | No |
| 003 | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | CAPSULE;ORAL | EQ 400MG BASE | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018917-001 | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | |
| N018917-003 | SECTRAL | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 |
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| 2026-02 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Acebutolol Hydrochloride | ACEBUTOLOL HYDROCHLORIDE | AvKARE | fa40a564-a579-15c1-e053-6294a90ad8e9 | 2026-01-13 | Warnings, Adverse reactions | ACEBUTOLOL HYDROCHLORIDE |
| Acebutolol Hydrochloride | ACEBUTOLOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | f037a079-fde6-3588-e053-2995a90a6621 | 2025-12-17 | Warnings, Adverse reactions | ACEBUTOLOL HYDROCHLORIDE |
| Acebutolol Hydrochloride | ACEBUTOLOL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 48bded12-09c7-47f2-b162-ec970a77f2d8 | 2025-11-07 | Warnings, Adverse reactions | ACEBUTOLOL HYDROCHLORIDE |
| Acebutolol Hydrochloride | ACEBUTOLOL HYDROCHLORIDE | AvPAK | ff68a002-d46d-4f9f-0705-427844ea3655 | 2025-09-18 | Warnings, Adverse reactions | ACEBUTOLOL HYDROCHLORIDE |
| Acebutolol Hydrochloride | ACEBUTOLOL HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | fe2cd5c0-ee16-4bcb-ad92-3755881dbe79 | 2024-12-11 | Warnings, Adverse reactions | ACEBUTOLOL HYDROCHLORIDE |
| Acebutolol Hydrochloride | ACEBUTOLOL HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 28f8c26c-a1e1-4485-a45f-05c82f7a34b5 | 2024-10-23 | Warnings, Adverse reactions | ACEBUTOLOL HYDROCHLORIDE |