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 | Unit Dose Solutions, Inc. | 53704ffd-b4f6-8b61-e063-6394a90a01f9 | 2026-06-04 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | 7059a0b2-dd57-4fc1-ac3d-6aead35a4b08 | 2026-06-01 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| cephalexin | CEPHALEXIN | Lupin Pharmaceuticals, Inc. | 25ef498a-7a7e-4543-a544-b9d0e99f9cd9 | 2026-06-01 | Warnings, Adverse reactions | cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | c600a2c0-42ab-4be8-b9b1-59ba39494b3f | 2026-05-13 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Coupler LLC | 508a3401-df0b-0555-e063-6294a90a155a | 2026-04-28 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 47b6bc70-e8cc-4837-a39a-6998ee4e37dc | 2026-04-20 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 8a938dd0-fca6-4f22-9fb0-632596603001 | 2026-04-20 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | 2506895d-f3e0-4be9-95cb-7a6fd44de46d | 2026-04-03 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 06c2fb2e-0539-4f16-bac4-e15a575ca802 | 2026-04-03 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | b73593ce-0b1f-4371-bae1-140742de3b42 | 2026-04-01 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| CEPHALEXIN | CEPHALEXIN | Direct_Rx | 90051655-77e9-6753-e053-2a95a90a462c | 2026-03-26 | Warnings, Adverse reactions | CEPHALEXIN CEPHALEXIN |
| cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 553485f8-890d-4929-a6bb-905221cf411d | 2026-03-25 | Warnings, Adverse reactions | cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticlas Inc. | fbf5fcdf-40fc-40e5-b784-308032fff0e5 | 2026-03-25 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals, Inc. | 6c7bfa58-2d38-4607-8c33-485ba4931c68 | 2026-03-25 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 52d8a080-eafc-46fe-82d9-6b69c6a3a38a | 2026-03-25 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | ad676021-44f3-4a97-a3dc-28a62fe982bb | 2026-03-25 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Sportpharm LLC | da97ca40-3b22-432b-a3e9-0902dbef06a9 | 2026-03-21 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | 3fed2817-fc0d-43cd-9f02-948fbc76672c | 2026-03-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | a24a3c7c-c0f8-4107-ab30-751bea743d2d | 2026-03-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| CEPHALEXIN | CEPHALEXIN | Direct_Rx | 90148caf-4291-da8b-e053-2a95a90a9bd3 | 2026-03-16 | Warnings, Adverse reactions | CEPHALEXIN CEPHALEXIN |