Application 050617
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERYGEL | ERYTHROMYCIN | GEL;TOPICAL | 2% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050617-001 | ERYGEL | ERYTHROMYCIN | 2% | GEL / TOPICAL | RLD | 1987-10-21 |
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 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | RLD | 1987-10-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | RLD | 1987-10-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | RLD | 1987-10-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | RLD | 1987-10-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050617-001 | ERYGEL | 2% | GEL / TOPICAL | AT | RLD, RS | 1987-10-21 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | N050617-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050617-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050617-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050617-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050617-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050617-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050617-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050617-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050617-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050617-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050617-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050617-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050617-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050617-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050617-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050617-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050617-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050617-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050617-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050617-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050617-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050617-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050617-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050617-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050617-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050617-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050617-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050617-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050617-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050617-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050617-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050617-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050617-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050617-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050617-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050617-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050617-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050617-001 | AT | 1 | cb3db0bc1861… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8075 | ERYGEL | erythromycin | Mylan Pharmaceuticals Inc. | NDA | Current |
| 0378-8075 | ERYGEL | erythromycin | Mylan Pharmaceuticals Inc | NDA | Current |
| 0378-8212 | Erythromycin | erythromycin | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 40076-415 | ERYGEL | erythromycin | Prestium Pharma, Inc. | NDA | Current |
| 40076-415 | ERYGEL | erythromycin | Prestium Pharma, Inc. | NDA | Current |
| 40085-315 | Erythromycin | erythromycin | Renaissance Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |