Application 061639
- Type
- ANDA
- Sponsor
- ARBOR PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | E.E.S. 200 | ERYTHROMYCIN ETHYLSUCCINATE | SUSPENSION;ORAL | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | SUSPENSION;ORAL | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A061639-001 | E.E.S. 200 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | ||
| A061639-002 | E.E.S. 400 | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 |
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 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML | SUSPENSION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML | SUSPENSION / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML | SUSPENSION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML | SUSPENSION / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUSPENSION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUSPENSION / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A061639-001 | E.E.S. 200 | EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUSPENSION / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A061639-002 | E.E.S. 400 | EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUSPENSION / ORAL | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| E.E.S 400 | ERYTHROMYCIN ETHYLSUCCINATE | REMEDYREPACK INC. | 49b3ca93-43cc-439c-8f5d-e3ea2e87ad2f | 2026-06-23 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | Bryant Ranch Prepack | 78139f33-0965-4bbb-a53f-6d7fd4fa9a81 | 2026-06-05 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | Bryant Ranch Prepack | 1d9eb7cb-0b11-4f6e-8a9c-1bcff37fe0b5 | 2026-06-05 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | Kanchan Healthcare Inc | a7f7faaf-dc05-4d51-86c6-bf5d61562e48 | 2026-04-08 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | ANI Pharmaceuticals, Inc. | 3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f | 2025-06-20 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | ANI Pharmaceuticals, Inc. | 3de1e0b9-473b-44c0-a644-5fa14ad69a83 | 2025-06-20 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | Nivagen Pharmaceuticals, Inc. | 46f74c4f-10fc-44cf-aec4-d113f49149bc | 2024-01-02 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| E.E.S 400 | ERYTHROMYCIN ETHYLSUCCINATE | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | b455bbdb-a3f1-470f-aa5f-ed83ac2e228d | 2023-12-16 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Ery-Ped | ERYTHROMYCIN ETHYLSUCCINATE | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 04775721-ab87-4b66-808c-d67a21032385 | 2023-12-16 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 23a0564e-dca9-41bc-b2c7-0461169f65f9 | 2023-12-16 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | Cadila Pharmaceuticals Limited | db70798e-5e07-41d6-afe9-82c272bc5cc0 | 2023-11-11 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | Wilshire Pharmaceuticals | 86d6353c-2b58-4219-b31d-fb5b97789094 | 2020-09-24 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN ETHYLSUCCINATE | Wilshire Pharmaceuticals Inc. | f4a3fffd-ce02-450f-bbcc-d425374e3e32 | 2019-01-29 | Warnings, Adverse reactions | ERYTHROMYCIN ETHYLSUCCINATE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 39395 | SUPPL | 2014-01-31 |