Application 065135
- Type
- ANDA
- Sponsor
- LUPIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | TABLET;ORAL | EQ 250MG BASE | No | No |
| 002 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | TABLET;ORAL | EQ 500MG BASE | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065135-001 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | 2003-07-25 | ||
| A065135-002 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | 2003-07-25 |
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 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | 2003-07-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | 2003-07-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | 2003-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | 2003-07-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | 2003-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | 2003-07-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065135-001 | CEFUROXIME AXETIL | EQ 250MG BASE | TABLET / ORAL | AB | 2003-07-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065135-002 | CEFUROXIME AXETIL | EQ 500MG BASE | TABLET / ORAL | AB | RS | 2003-07-25 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A065135-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065135-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065135-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065135-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065135-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065135-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065135-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065135-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065135-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065135-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065135-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065135-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065135-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065135-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065135-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065135-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065135-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065135-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065135-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065135-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065135-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065135-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065135-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065135-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065135-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065135-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065135-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065135-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065135-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065135-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065135-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065135-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065135-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065135-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065135-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065135-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065135-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065135-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065135-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A065135-002 | AB | 1 | 5aa47cf7b7d7… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43063-584 | cefuroxime axetil | cefuroxime axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-584 | cefuroxime axetil | cefuroxime axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-584 | cefuroxime axetil | cefuroxime axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-584 | cefuroxime axetil | cefuroxime axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-584 | cefuroxime axetil | cefuroxime axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 49999-785 | cefuroxime axetil | cefuroxime axetil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0798 | cefuroxime axetil | cefuroxime axetil | A-S Medication Solutions | ANDA | Current |
| 57297-302 | cefuroxime axetil | cefuroxime axetil | LUPIN LIMITED | ANDA | Current |
| 57297-303 | cefuroxime axetil | cefuroxime axetil | LUPIN LIMITED | ANDA | Current |
| 60429-656 | cefuroxime axetil | cefuroxime axetil | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-656 | cefuroxime axetil | cefuroxime axetil | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-656 | cefuroxime axetil | cefuroxime axetil | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-657 | cefuroxime axetil | cefuroxime axetil | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-657 | cefuroxime axetil | cefuroxime axetil | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-657 | cefuroxime axetil | cefuroxime axetil | Golden State Medical Supply, Inc. | ANDA | Current |
| 68180-302 | cefuroxime axetil | cefuroxime axetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-302 | cefuroxime axetil | cefuroxime axetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-302 | cefuroxime axetil | cefuroxime axetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-303 | cefuroxime axetil | cefuroxime axetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-303 | cefuroxime axetil | cefuroxime axetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-303 | cefuroxime axetil | cefuroxime axetil | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9700 | cefuroxime axetil | cefuroxime axetil | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9701 | cefuroxime axetil | cefuroxime axetil | Preferred Pharmaceuticals, Inc. | ANDA | Current |