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| ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | |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| ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 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| 2022-03 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | bb7c543d1eb4… | |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| 2022-03 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | bb7c543d1eb4… | |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| 2021-12 | N018917-001 | SECTRAL | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 782e0a99824c… | |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| 2021-12 | N018917-003 | SECTRAL | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 1984-12-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018917-001 | SECTRAL | EQ 200MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018917-003 | SECTRAL | EQ 400MG BASE | CAPSULE / ORAL | RLD | 1984-12-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | 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 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | 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 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | 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 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | 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 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | 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 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | 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 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | 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 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | 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 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | 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 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | 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 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | 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 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | 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 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | 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 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | 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 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | 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 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | 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 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | 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 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | 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 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | 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 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | 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 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | 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 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | 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 | f41ea6bd6efb… |
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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.