Application 062869
- Type
- ANDA
- Sponsor
- STEVENS J
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062869-001 | CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 |
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 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062869-001 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 1988-03-17 | 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 |
|---|---|---|---|---|---|---|
| Cephalexin | CEPHALEXIN | AvKARE | 03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d | 2026-07-29 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 88426cb3-1c0c-439b-9f1a-aa169040c29f | 2026-07-23 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | a6b5edf2-1ef8-46b7-977a-8c303900f3f0 | 2026-07-22 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Aurobindo Pharma Limited | 655f38e8-1c4d-4cbc-9f52-bb881f065b2d | 2026-07-21 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 0384c418-b4d4-4c06-9ed9-13e864b1980b | 2026-07-16 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | d6954168-9c7f-4a6c-9262-2e6bed5c9f24 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 7508351d-69fe-457c-b450-9a2343be2587 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 980b9dd9-cb61-4c4f-81ac-85ee5a7c2497 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 759c3856-8d3a-4036-926c-8508b573c736 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 5b9b212a-3a3e-4637-b23c-6d66d8cf1171 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 11cfefee-d75e-430c-8817-02dc57de0e88 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 43ca66ae-2ada-412d-bc5d-f53602f535a5 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | cf1c5d03-eddc-463a-84ad-4d59362c2cf8 | 2026-07-14 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | HAWAII REPACK, INC. | d54abc0a-3c8f-4f02-bd55-406f0c5b925a | 2026-07-13 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Northwind Health Company, LLC | 1d0d50ba-8c2c-855c-e063-6394a90a5c7d | 2026-07-09 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Northwind Health Company, LLC | 4ecf9314-76e2-c270-e063-6294a90ad8db | 2026-07-09 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | e54df878-c235-4aa3-af33-fe5287c73138 | 2026-06-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Ascend Laboratories, LLC | 4fec8daf-6e09-4153-926f-64709dbdd26c | 2026-06-17 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | b3bb8222-161e-4d9c-8e08-7e22ad65bf72 | 2026-06-16 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | 8499aa5a-49b1-4555-bd27-6177d92b261d | 2026-06-09 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |