Application 201126
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201126-001 | ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A201126-001 | ESMOLOL HYDROCHLORIDE | 10MG/ML | INJECTABLE / INJECTION | 2015-02-20 | 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 |
|---|---|---|---|---|---|---|
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | REMEDYREPACK INC. | 1f5707f2-a8a7-4a5f-b846-64585b5e3f9f | 2026-09-10 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| Brevibloc | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc | 38a8b23a-fca8-45f4-a09a-9c8b21f522cd | 2026-08-06 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | ProPharma Distribution | 3853a26d-782d-f4e7-e063-6294a90a6e47 | 2025-12-18 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc. | 9c1e3a64-0ef0-4071-ad6f-63ff8789b198 | 2025-06-18 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 220a07b8-5c68-41a3-8705-fd91f14c50b4 | 2025-03-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| BREVIBLOC | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 9c593cdb-cdfe-4492-8862-9b05116aa25e | 2025-03-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Brevibloc | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Company | 595cc3d5-1306-4828-aefa-5595219ffd62 | 2025-03-14 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Mylan Institutional LLC | 94f069f9-dd52-4a69-a103-ebdb4294f088 | 2025-02-27 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | Henry Schein, Inc. | 519cc19c-e2b6-4984-bfad-45276d4cf0e6 | 2025-01-27 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9a3e69ab-3ffe-33af-e053-2a95a90a6524 | 2025-01-08 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Fresenius Kabi USA, LLC | fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2 | 2024-11-14 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Eugia US LLC | ac22475d-2d78-469f-9435-b403ac4ee380 | 2024-09-17 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE | WG Critical Care, LLC | 59ba978b-a393-421c-9a67-77e690249d88 | 2024-06-28 | Warnings, Adverse reactions | Esmolol Hydrochloride |
| Esmolol Hydrochloride in Water | ESMOLOL HYDROCHLORIDE | WG Critical Care, LLC | 60b10020-f802-4fef-a487-0f11eca246c5 | 2024-05-31 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE | Amneal Pharmaceuticals LLC | 4cfdfa50-579b-43e7-bc0a-e831d3099bfd | 2024-04-19 | Warnings, Adverse reactions | Esmolol Hydrochloride |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 789730fa-eaca-4986-e053-2a91aa0a5339 | 2024-02-19 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE |
| ESMOLOL HYDROCHLORIDE | ESMOLOL HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9a52d2fd-e551-f8f1-e053-2995a90a6c09 | 2024-01-29 | Warnings, Adverse reactions | ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE |
| esmolol hydrochloride | ESMOLOL HYDROCHLORIDE | Sagent Pharmaceuticals | f12fb0fd-fa05-49fc-b5e3-a2050b816ef2 | 2023-07-12 | Warnings, Adverse reactions | esmolol hydrochloride ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Gland Pharma Limited | 017023a9-00f0-4284-861f-a3634d4fdb17 | 2023-06-23 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |
| Esmolol Hydrochloride | ESMOLOL HYDROCHLORIDE | Baxter Healthcare Corporation | f0a56c07-8f0f-4499-8d00-f13a966bf988 | 2023-06-15 | Warnings, Adverse reactions | Esmolol Hydrochloride ESMOLOL HYDROCHLORIDE |