Application 065215
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 250MG BASE | No | No |
| 002 | 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 |
|---|---|---|---|---|---|---|---|
| A065215-001 | CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | ||
| A065215-002 | CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 |
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 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | 2006-01-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | 2006-01-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065215-001 | CEPHALEXIN | EQ 250MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065215-002 | CEPHALEXIN | EQ 500MG BASE | CAPSULE / ORAL | AB | 2006-01-24 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065215-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065215-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065215-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065215-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065215-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065215-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065215-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065215-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065215-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065215-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065215-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065215-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065215-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065215-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065215-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A065215-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065215-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A065215-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065215-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A065215-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065215-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A065215-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065215-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065215-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065215-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065215-002 | AB | 1 | ea99ee380514… |
| 2023-12-20 04:57 UTC | 2023-12 | A065215-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A065215-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065215-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065215-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065215-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065215-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065215-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065215-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065215-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065215-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065215-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A065215-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065215-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A065215-002 | AB | 1 | 3bdfa0b2c4d7… |
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 | Bryant Ranch Prepack | 4fccce5a-4e39-46cd-976a-32ff71189520 | 2024-03-08 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 92be9844-0775-4808-bdeb-dccb09647d91 | 2024-03-07 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| cephalexin | CEPHALEXIN | A-S Medication Solutions | d31da5be-c939-4aa0-adb8-b26a1396b228 | 2024-02-22 | Warnings, Adverse reactions | cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 0edeb103-5e94-4f42-828f-c7336486c784 | 2024-02-15 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af10128f-021a-14b7-e053-2a95a90a4365 | 2024-01-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | f501f3a9-48e9-451a-a4b6-46d268b7bd3d | 2024-01-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 8d25d863-9ec2-4b76-b2e5-d4e2e39639a5 | 2024-01-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Advanced Rx Pharmacy of Tennessee, LLC | b6ffe633-dd91-6d49-e053-2a95a90a5ac6 | 2024-01-17 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 9a1f2ab7-d8af-444f-96c2-56b666d4c79a | 2024-01-15 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | ea10d05a-2e39-4a30-8935-5555bc1e515e | 2024-01-15 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | ab3fc544-3652-4de5-a7ff-e013adb69b5a | 2024-01-09 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Aurobindo Pharma Limited | f957ea27-2906-40c7-ac03-eb2f742473a0 | 2023-12-28 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | ee0603a5-0758-4968-89e3-1aa95e9967f2 | 2023-12-12 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 7cbdfa7f-2ea0-48e1-b506-59f58e5685a6 | 2023-12-11 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 18518154-30ba-48a4-852a-3a7723030071 | 2023-12-07 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| cephalexin | CEPHALEXIN | Proficient Rx LP | 829244bd-93da-4a5a-a257-890cfec4c06d | 2023-12-01 | Warnings, Adverse reactions | cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Major Pharmaceuticals | 1c1fbad7-bef4-42a0-a8c9-b35168f5d533 | 2023-11-07 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 2cb7bc3a-988b-4414-8036-fb09b2ab5767 | 2023-10-23 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | b270d537-878b-4468-b246-b704adb29ced | 2023-10-23 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Teva Pharmaceuticals USA, Inc. | 445b2a87-2e4f-483a-abe8-26fefd67514a | 2023-10-01 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9897 | Cephalexin | Cephalexin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9897 | Cephalexin | Cephalexin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9898 | Cephalexin | Cephalexin | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9898 | Cephalexin | Cephalexin | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0440-1243 | Cephalexin | Cephalexin | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 10544-066 | Cephalexin | Cephalexin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-617 | Cephalexin | Cephalexin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 52959-031 | Cephalexin | Cephalexin | H.J. Harkins Company, Inc. | ANDA | Current |
| 61786-277 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 63874-111 | Cephalexin | Cephalexin | Altura Pharmaceuticals, Inc. | ANDA | Current |
| 63874-112 | Cephalexin | Cephalexin | Altura Pharmaceuticals, Inc. | ANDA | Current |
| 66116-398 | Cephalexin | Cephalexin | MedVantx, Inc. | ANDA | Current |