Application 060272
- Type
- ANDA
- Sponsor
- ARBOR PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | E-MYCIN | ERYTHROMYCIN | TABLET, DELAYED RELEASE;ORAL | 250MG | No | No |
| 002 | E-MYCIN | ERYTHROMYCIN | TABLET, DELAYED RELEASE;ORAL | 333MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A060272-001 | E-MYCIN | ERYTHROMYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | ||
| A060272-002 | E-MYCIN | ERYTHROMYCIN | 333MG | TABLET, DELAYED RELEASE / 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 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A060272-001 | E-MYCIN | 250MG | TABLET, DELAYED RELEASE / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A060272-002 | E-MYCIN | 333MG | TABLET, DELAYED RELEASE / 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 |
|---|---|---|---|---|---|---|
| Erythromycin | ERYTHROMYCIN | Sportpharm LLC | 790d3e3e-df69-45f7-97d5-da65faa46556 | 2026-07-21 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 50c8d6b3-4660-e829-e063-6294a90a919b | 2026-05-01 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Cardinal Health 107, LLC | ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5 | 2026-04-27 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Golden State Medical Supply, Inc. | 0c05e1f7-a3d4-8e69-e063-6394a90aecc3 | 2026-04-21 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Preferred Pharmaceuticals, Inc. | ee3d806e-65ce-42e1-b170-7b35bcb7b06a | 2026-04-10 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Sentiss Pharmaceuticals LLC | 4da0e351-383f-55da-e063-6394a90a8eba | 2026-03-31 | Adverse reactions | ERYTHROMYCIN |
| ERYTHROMYCIN | ERYTHROMYCIN | Direct Rx | 9ac4dcd2-8cac-404d-b651-da74062d30ed | 2026-03-17 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Torrent Pharmaceuticals Limited | 933049f6-61b9-4ed5-b6b7-60c5037e2115 | 2026-03-05 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | REMEDYREPACK INC. | c49ad63b-c2fd-4535-bec0-6415c93cf847 | 2026-01-09 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Redpharm Drug | 301ee5ad-3b6c-1152-e063-6294a90a54e7 | 2025-12-23 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | A-S Medication Solutions | 2be16639-b153-407b-b43d-3a2bcf66151e | 2025-12-03 | Adverse reactions | ERYTHROMYCIN |
| Ery | ERYTHROMYCIN | Padagis Israel Pharmaceuticals Ltd | 9a63da11-01be-4c63-a260-e6bdbb4a7a69 | 2025-10-31 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | PD-Rx Pharmaceuticals, Inc. | e54d66fa-93bb-4339-a75e-194a2e4488aa | 2025-10-20 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Bryant Ranch Prepack | 10ad1391-32fc-40c0-96d0-675f3c91429f | 2025-10-20 | Warnings, Adverse reactions | ERYTHROMYCIN |
| ERYTHROMYCIN | ERYTHROMYCIN | Ascend Laboratories, LLC | 3b415e31-e5d4-4990-8021-78459af73372 | 2025-10-17 | Warnings, Adverse reactions | ERYTHROMYCIN |
| erythromycin | ERYTHROMYCIN | Dr. Reddy's Labratories Inc. | a2dcb48a-212c-1b0c-ec35-ee2ade85847f | 2025-09-25 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | A-S Medication Solutions | 99eb7dbc-6ba9-4122-ad1e-5cae73186932 | 2025-05-02 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin Ethylsuccinate | ERYTHROMYCIN | Amneal Pharmaceuticals NY LLC | 581d7430-1a80-42a6-befb-4c3ae8140392 | 2025-04-25 | Warnings, Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | Bausch & Lomb Incorporated | 061ddd20-94a6-4e3c-ba84-1ebd8529eea6 | 2025-04-22 | Adverse reactions | ERYTHROMYCIN |
| Erythromycin | ERYTHROMYCIN | ST. MARY'S MEDICAL PARK PHARMACY | 2cc726c2-3746-6dbf-e063-6294a90a789f | 2025-01-28 | Adverse reactions | ERYTHROMYCIN |