Application 050611
- Type
- NDA
- Sponsor
- ARBOR PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PCE | ERYTHROMYCIN | TABLET, COATED PARTICLES;ORAL | 333MG | Yes | No |
| 002 | PCE | ERYTHROMYCIN | TABLET, COATED PARTICLES;ORAL | 500MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050611-001 | PCE | ERYTHROMYCIN | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | |
| N050611-002 | PCE | ERYTHROMYCIN | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 |
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 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050611-001 | PCE | 333MG | TABLET, COATED PARTICLES / ORAL | RLD | 1986-09-09 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050611-002 | PCE | 500MG | TABLET, COATED PARTICLES / ORAL | RLD | 1990-08-22 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Erythromycin | ERYTHROMYCIN | Wilshire Pharmaceuticals | e9b5abbb-2952-44ce-8cbb-415d9be23df4 | 2024-12-13 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Amneal Pharmaceuticals NY LLC | bb641ed4-8093-4e15-9cb9-8921b1093d50 | 2024-12-10 | Warnings, Adverse reactions | ERYTHROMYCIN |
| ERYTHROMYCIN | ERYTHROMYCIN | Golden State Medical Supply, Inc. | 0c0560be-fb11-509d-e063-6394a90ab6f7 | 2024-11-25 | Warnings, Adverse reactions | ERYTHROMYCIN |
| ERYTHROMYCIN | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | 66b0d891-8756-43d1-b046-6dba787dd96f | 2024-10-17 | Warnings, Adverse reactions | ERYTHROMYCIN |
| erythromycin | ERYTHROMYCIN | Bryant Ranch Prepack | 00c4f27e-59e2-4173-99b1-59dd295e83de | 2024-10-11 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 5568ade8-bdc2-1a32-e054-00144ff8d46c | 2024-08-14 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Teva Pharmaceuticals USA, Inc. | 75a0bd5a-d09f-483b-bfd8-f8343b149eb2 | 2024-08-01 | Warnings, Adverse reactions | ERYTHROMYCIN |
| erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 8349b4ec-3ca6-bdb6-e053-2a91aa0a8b63 | 2024-06-14 | Warnings, Adverse reactions | ERYTHROMYCIN |
| erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 84119a8f-78d1-2882-e053-2a91aa0a6faa | 2024-06-14 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 6296e2ed-334c-b9af-e053-2991aa0aae0c | 2024-06-06 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Zydus Pharmaceuticals USA Inc. | 0277341c-8513-4317-9334-c242f97630c1 | 2024-03-20 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN | Amneal Pharmaceuticals NY LLC | 596fa019-b0eb-4e57-93ff-195a765a2e91 | 2023-12-29 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Modavar Pharmaceuticals LLC | bc3d091b-1fc8-4f7a-a3c2-8ede87f5faa0 | 2023-12-23 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Cadila Pharmaceuticals Limited | fae8fc38-3c60-43b8-a0f9-2c50df332505 | 2023-12-22 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Fera Pharmaceuticals, LLC | be59bb85-8ef4-4f9e-85e5-c05662ecd1ee | 2023-10-26 | ERYTHROMYCIN | |
| Erythromycin | ERYTHROMYCIN | ARMAS PHARMACEUTICALS INC. | 07fdeac5-f690-d74b-e063-6394a90a5c5b | 2023-10-23 | Adverse reactions | ERYTHROMYCIN |
| erythromycin | ERYTHROMYCIN | Asclemed USA, Inc. | 6186510d-62ca-4083-9895-8d028d71b510 | 2023-09-12 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Alembic Pharmaceuticals Limited | 904b9ab6-9a2a-47f3-8a38-04920ce696e0 | 2023-08-29 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Alembic Pharmaceuticals Inc. | 383f9011-a3e0-4d7d-b058-5f8ab319dc8c | 2023-08-25 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Bryant Ranch Prepack | b7d11564-c92d-4eed-bdd9-8fc355e7dfc7 | 2023-08-16 | Warnings, Adverse reactions | ERYTHROMYCIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53808 | SUPPL | 2018-04-24 |
| 53801 | SUPPL | 2018-04-24 |
| 30170 | SUPPL | 2012-02-06 |
| 17930 | SUPPL | 2012-02-06 |
| 30169 | SUPPL | 2011-02-07 |
| 39039 | SUPPL | 2011-01-31 |
| 7886 | SUPPL | 2010-11-08 |
| 17929 | SUPPL | 2009-01-02 |
| 7887 | SUPPL | 2008-12-19 |
| 7885 | SUPPL | 2008-05-28 |
| 7884 | SUPPL | 2008-01-09 |
| 39040 | SUPPL | 2008-01-08 |
| 30167 | SUPPL | 2006-08-14 |
| 39038 | SUPPL | 2006-08-11 |
| 42659 | SUPPL | 2004-09-21 |
| 30168 | SUPPL | 2004-03-16 |
| 30166 | SUPPL | 2002-04-25 |