Application 062745
- Type
- ANDA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KEFLET | CEPHALEXIN | TABLET;ORAL | EQ 250MG BASE | No | No |
| 002 | KEFLET | CEPHALEXIN | TABLET;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062745-001 | KEFLET | CEPHALEXIN | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | ||
| A062745-002 | KEFLET | CEPHALEXIN | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 |
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 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | 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 |
|---|---|---|---|---|---|---|
| Cephalexin | CEPHALEXIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af4abf8b-22cc-da58-e053-2a95a90aa766 | 2024-12-31 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Aurobindo Pharma Limited | 8e28f049-6110-4473-830f-c494191a7197 | 2024-12-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | American Health Packaging | cb64cab2-5297-4ed2-a50a-2e5d5e14fa8d | 2024-12-17 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | a8f14231-5d43-46f7-ba1f-d6de8162d5e7 | 2024-11-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 99ef59d5-bc44-4727-86fe-dc81357207c3 | 2024-10-25 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 65b38519-1d8a-4aca-b415-c64cca84d085 | 2024-10-25 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Ascend Laboratories, LLC | 36882c6d-7b6f-41e3-8c54-e3b0073b8c07 | 2024-10-18 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Chartwell RX, LLC. | 3c459965-2d42-488b-80c4-ce801f94839c | 2024-10-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Aurobindo Pharma Limited | e46059e1-3ce9-4a3c-80ce-464b140600ce | 2024-09-28 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals, Inc. | 216660f3-0329-ef7d-e063-6294a90a17df | 2024-09-05 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | fe6fff2f-f95c-4057-a71b-7ef6c5d415cc | 2024-09-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | e186afb5-7531-45ea-b785-c230483a7747 | 2024-08-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | f1439d25-3d3d-4fe5-b6e7-d76e62892969 | 2024-08-15 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 549bf887-1ef6-6a75-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 31afe835-8ec8-4ac0-8a2a-c3e9283fa6ea | 2024-08-08 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 8a691ff2-eb16-4357-87ee-0ac9c99a5cb7 | 2024-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 9694f7a6-bcec-4809-b261-cdd3740968cb | 2024-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | e43271ef-c145-4145-b7f0-a02c237de2b5 | 2024-08-02 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 28fec572-e3b9-448c-8626-5c0920f38eeb | 2024-07-30 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | df6bb893-e3d7-4c8f-8cec-35b4d2fa33b3 | 2024-07-26 | Warnings, Adverse reactions | CEPHALEXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.