Application 050675
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANTIN | CEFPODOXIME PROXETIL | FOR SUSPENSION;ORAL | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | VANTIN | CEFPODOXIME PROXETIL | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N050675-001 | VANTIN | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | |
| N050675-002 | VANTIN | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 |
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2026-08 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050675-001 | VANTIN | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N050675-002 | VANTIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050675-001 | VANTIN | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N050675-002 | VANTIN | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050675-001 | VANTIN | EQ 50MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N050675-002 | VANTIN | EQ 100MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | FOR SUSPENSION / ORAL | RLD | 1992-08-07 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | Redpharm Drug | 59d848e9-de7a-669b-e063-6394a90a2b35 | 2026-08-25 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Sandoz Inc | 8519a9d8-7106-4545-bc58-859ee9a6708e | 2026-07-30 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | REMEDYREPACK INC. | dae9cbf2-65b5-49fa-898b-924c39b86c57 | 2026-06-04 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Rising Pharma Holdings, Inc. | edf589b2-f796-4522-a5e6-2bd0a833922f | 2025-06-06 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Golden State Medical Supply, Inc. | fb313728-09f1-aff8-e053-6394a90a30a8 | 2025-02-18 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | NuCare Pharmaceuticals,Inc. | fe827f61-9336-72e7-e053-6394a90af75f | 2025-02-06 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | NuCare Pharmaceuticals,Inc. | 1b405104-650b-c8e3-e063-6294a90a9e8a | 2024-06-19 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | Cronus Pharma LLC | bc9c338c-1fc7-4bc2-a357-a78e433cbe9d | 2024-01-04 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | NorthStar Rx LLC | 5310de78-22c3-4bee-9956-854e767b6bef | 2024-01-04 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Aurobindo Pharma Limited | 63777889-d306-4fc3-88da-b24859040ef4 | 2024-01-04 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | Aurobindo Pharma Limited | c36f2137-98bb-4583-89f7-6bce9582c465 | 2024-01-03 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | NorthStar Rx LLC | 4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9 | 2024-01-03 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Amici Pharmaceuticals, LLC. | 9d6d7f50-9838-47e3-8214-53e2dbeeadea | 2023-07-13 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Ascend Laboratories, LLC | ce5646cb-a450-4c2c-8499-6ecf71b12b0e | 2023-04-14 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Ascend Laboratories, LLC | 5d5ca5b6-282b-4683-908c-854782255739 | 2022-05-20 | Warnings, Adverse reactions | CEFPODOXIME PROXETIL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.