Application 065409
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | FOR SUSPENSION;ORAL | EQ 50MG BASE/5ML | No | No |
| 002 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065409-001 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | ||
| A065409-002 | CEFPODOXIME PROXETIL | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 |
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 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065409-001 | CEFPODOXIME PROXETIL | EQ 50MG BASE/5ML | FOR SUSPENSION / ORAL | 2007-06-08 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065409-002 | CEFPODOXIME PROXETIL | EQ 100MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2007-06-08 | 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 |
|---|---|---|---|---|---|---|
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Rising Pharma Holdings, Inc. | edf589b2-f796-4522-a5e6-2bd0a833922f | 2025-06-06 | Warnings, Adverse reactions | 065409 ANDA065409 64980-403 64980-402 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | NorthStar Rx LLC | 5310de78-22c3-4bee-9956-854e767b6bef | 2024-01-04 | Warnings, Adverse reactions | 065409 ANDA065409 16714-403 16714-402 |
| Cefpodoxime Proxetil | CEFPODOXIME PROXETIL | Aurobindo Pharma Limited | 63777889-d306-4fc3-88da-b24859040ef4 | 2024-01-04 | Warnings, Adverse reactions | 065409 ANDA065409 65862-140 65862-141 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 16714-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | NorthStar Rx LLC | ANDA | Current |
| 64980-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-402 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-403 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 65862-140 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-140 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-140 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-141 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-141 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-141 | Cefpodoxime Proxetil | Cefpodoxime Proxetil | Aurobindo Pharma Limited | ANDA | Current |