Application 050605
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | CEFTIN | CEFUROXIME AXETIL | TABLET;ORAL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050605-001 | CEFTIN | CEFUROXIME AXETIL | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | |
| N050605-002 | CEFTIN | CEFUROXIME AXETIL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | |
| N050605-003 | CEFTIN | CEFUROXIME AXETIL | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 |
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| 2026-08 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050605-002 | CEFTIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050605-003 | CEFTIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050605-001 | CEFTIN | EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-12-28 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Cefuroxime Axetil | CEFUROXIME AXETIL | REMEDYREPACK INC. | 76cec54f-d167-4298-951b-5411a3c47f4a | 2026-08-05 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Redpharm Drug | 56cb6f42-9ae1-38e7-e063-6294a90a3feb | 2026-07-31 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | 85cdd8d9-557e-4d15-855a-027e7809cf64 | 2026-05-14 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | d14d4184-3e29-43cd-8046-658699c70f03 | 2026-05-14 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | Golden State Medical Supply, Inc. | bb7955fe-5111-1662-e053-2a95a90a85a1 | 2026-04-23 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | NuCare Pharmaceuticals, Inc. | 4e4426a4-0ca9-dad5-e063-6294a90a5fdb | 2026-03-30 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | a84ac4ed-c268-4e9f-9df8-256e0a64cd16 | 2026-03-18 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | a940ba01-2b53-4947-9019-d3d8f4e9ad80 | 2026-01-23 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | Advanced Rx of Tennessee, LLC | 48d96608-d3da-b512-e063-6294a90a07d5 | 2026-01-16 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | Redpharm Drug | 3744f28c-c7e1-259c-e063-6294a90a10ed | 2025-12-11 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | 2af8f061-c0e1-3a1c-e054-00144ff8d46c | 2025-10-15 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | 2af94304-8118-41c7-e054-00144ff8d46c | 2025-10-15 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | aa6685c1-51ed-466a-ae7f-89a82986a7b1 | 2025-10-08 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | A-S Medication Solutions | 119c4d09-2324-498f-9318-1f8db49ad4b6 | 2025-10-08 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | Ascend Laboratories, LLC | dd11e4b9-7730-4d3a-81ca-16f15de09759 | 2025-10-03 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | NuCare Pharmaceuticals, Inc. | 3f92c452-18b4-5af8-e063-6394a90aaa53 | 2025-09-24 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | Major Pharmaceuticals | 44e1fb4d-4b61-40da-9974-0bd2006eb828 | 2025-09-12 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | American Health Packaging | f38418a7-dd90-4f20-b747-7ac086c53015 | 2025-08-06 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime Axetil | CEFUROXIME AXETIL | Preferred Pharmaceuticals Inc. | bc9200d2-4a6d-4847-ba85-8e9d378390de | 2025-07-31 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
| Cefuroxime axetil | CEFUROXIME AXETIL | PD-Rx Pharmaceuticals, Inc. | 15cabe73-f39d-4798-a840-115fe94f8f96 | 2025-03-13 | Warnings, Adverse reactions | CEFUROXIME AXETIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 66686 | SUPPL | 2021-03-09 |
| 66662 | SUPPL | 2021-03-09 |
| 58451 | SUPPL | 2019-04-26 |
| 58434 | SUPPL | 2019-04-26 |
| 50086 | SUPPL | 2017-10-18 |
| 50071 | SUPPL | 2017-10-17 |
| 45977 | SUPPL | 2016-12-01 |
| 45950 | SUPPL | 2016-11-23 |
| 30156 | SUPPL | 2015-08-28 |
| 17922 | SUPPL | 2015-08-27 |
| 30155 | SUPPL | 2015-07-07 |
| 39033 | SUPPL | 2015-07-01 |
| 30154 | SUPPL | 2014-09-23 |
| 30153 | SUPPL | 2014-09-23 |
| 39032 | SUPPL | 2014-09-22 |
| 39031 | SUPPL | 2014-09-22 |
| 30152 | SUPPL | 2007-07-27 |
| 17921 | SUPPL | 2007-07-24 |
| 30151 | SUPPL | 2004-06-07 |
| 17920 | SUPPL | 2004-06-07 |
| 7876 | SUPPL | 2002-07-24 |
| 17919 | SUPPL | 2002-04-11 |
| 7875 | SUPPL | 2002-04-11 |
| 17918 | SUPPL | 2002-03-29 |
| 7874 | SUPPL | 2002-03-29 |
| 30150 | SUPPL | 1999-08-24 |
| 22166 | SUPPL | 1999-08-24 |