Application 050665
- Type
- NDA
- Sponsor
- CORDEN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFZIL | CEFPROZIL | FOR SUSPENSION;ORAL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CEFZIL | CEFPROZIL | FOR SUSPENSION;ORAL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050665-001 | CEFZIL | CEFPROZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | |
| N050665-002 | CEFZIL | CEFPROZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 |
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| 2026-07 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050665-001 | CEFZIL | 125MG/5ML | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050665-002 | CEFZIL | 250MG/5ML | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050665-001 | CEFZIL | 125MG/5ML | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050665-002 | CEFZIL | 250MG/5ML | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050665-001 | CEFZIL | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N050665-002 | CEFZIL | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1991-12-23 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Cefprozil | CEFPROZIL | NorthStar Rx LLC | 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4 | 2026-07-09 | Warnings, Adverse reactions | CEFPROZIL |
| CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | 800a2ec0-4798-4423-9613-d03024cf1f0e | 2026-05-04 | Warnings, Adverse reactions | CEFPROZIL |
| CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | 3ec55c0a-1456-412e-972f-352b3135c8f2 | 2025-10-10 | Warnings, Adverse reactions | CEFPROZIL |
| CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | 14527f4a-ce99-449d-a5a5-9edd7fb28dee | 2025-10-10 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | Ascend Laboratories, LLC | dc3e9cae-6f4f-4045-a11e-2fbf7f94c3c0 | 2025-05-30 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | A-S Medication Solutions | d5d28d57-1f3c-4c80-ad78-0f67635f5428 | 2025-01-30 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | Rising Pharma Holdings, Inc. | d7fac9cc-30e1-4762-a01b-04f1bd3b2a56 | 2024-05-18 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | Aurobindo Pharma Limited | 97675251-70b8-43bc-93ea-f9ef6bb8cb68 | 2024-05-18 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | NorthStar Rx LLC | 6133611e-19c1-4df2-8c23-8573aaf63020 | 2024-05-05 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | Aurobindo Pharma Limited | b9111a81-07c4-4458-b994-a4ad504986d8 | 2024-05-05 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | Rising Pharma Holdings, Inc. | af24a86f-8072-49a6-94ec-2f17fe81812b | 2024-05-05 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | A-S Medication Solutions | 8e292a8d-9fd6-45fb-8fb5-d8cb25a4b46d | 2024-01-26 | Warnings, Adverse reactions | CEFPROZIL |
| Cefprozil | CEFPROZIL | Teva Pharmaceuticals USA, Inc. | 3391de8b-7bc9-4624-a5c4-836135b39d99 | 2018-08-31 | Warnings, Adverse reactions | CEFPROZIL |