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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 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… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062745-001 | KEFLET | EQ 250MG BASE | TABLET / ORAL | 1986-12-01 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062745-002 | KEFLET | EQ 500MG BASE | TABLET / ORAL | 1986-12-01 | bb7c543d1eb4… |
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 | Preferred Pharmaceuticals Inc. | 52d8a080-eafc-46fe-82d9-6b69c6a3a38a | 2026-03-25 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | ad676021-44f3-4a97-a3dc-28a62fe982bb | 2026-03-25 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Sportpharm LLC | da97ca40-3b22-432b-a3e9-0902dbef06a9 | 2026-03-21 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | 3fed2817-fc0d-43cd-9f02-948fbc76672c | 2026-03-18 | Warnings, Adverse reactions | CEPHALEXIN |
| CEPHALEXIN | CEPHALEXIN | Direct_Rx | 90148caf-4291-da8b-e053-2a95a90a9bd3 | 2026-03-16 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Sportpharm LLC | 3d5a2665-65da-4b10-9e23-39fc88145da1 | 2026-02-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Sportpharm LLC | 75820198-5efe-4ba0-ad50-e88d22fe075e | 2026-02-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ee278959-d321-d356-e053-2995a90a32c2 | 2026-01-30 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Northwind Pharmaceuticals, LLC | 89bb3920-69bf-4818-b573-4bd845f6e2d5 | 2026-01-02 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | AVKARE | 74f83298-57f7-4166-8dd8-db3e556a68d8 | 2025-12-30 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Chartwell RX, LLC | 8a09bccd-1864-4dc3-9c31-6187d8e0fc99 | 2025-12-10 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Chartwell RX, LLC | d315cce8-9784-419e-818b-16d68d1dbd6e | 2025-12-10 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 13444dc7-7da1-4181-a9ac-d95d4a235e6d | 2025-12-10 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | QPharma Inc | a9d2e29e-9c3f-429d-9d22-481807becd33 | 2025-12-05 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | QPharma Inc | e8b3ece4-cf73-416c-8767-68f425df35f8 | 2025-12-05 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | QPharma Inc | 4e9a8ed3-c490-4a0e-bb29-5eea506f893b | 2025-12-04 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | QPharma Inc | c0e0533c-da78-7109-e053-2a95a90a4f5c | 2025-12-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 0b3da88f-f513-cdf0-e063-6394a90a7205 | 2025-12-01 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 11efa03d-0da9-419a-b53d-65a5671dccb0 | 2025-11-19 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | c7028200-b141-496b-89e9-491558d4c879 | 2025-11-10 | Warnings, Adverse reactions | CEPHALEXIN |