cefpodoxime Oral Tablet
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sandoz Inc (2014-07-28)
- Oldest Current Product
- 2007-06-11
- License(s)
- ANDA
- RxNORM
- ORAL TABLET\CEFPODOXIME
- FDAOB
- ORAL\TABLET\CEFPODOXIME PROXETIL
- SPL Active
- ORAL\TABLET, FILM COATED\CEFPODOXIME PROXETIL
- SPL Moiety
- ORAL\TABLET, FILM COATED\CEFPODOXIME
product(s) by strength(s)
cefpodoxime 100 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 007815438 | ANDA | Sandoz Inc | 2008-05-28 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065462 | 8519a9d8-7106-4545-bc58-859ee9a6708e |
| 2 | 167140394 | ANDA | Northstar Rx Llc | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065370 | 4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9 |
| 3 | 266370711 | ANDA | Putney, Inc. | 2008-05-28 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065462 | 91f2a366-97f3-4372-9803-f0e8afe89089 |
| 4 | 523430019 | ANDA | Lucid Pharma Llc | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065370 | 6a0f198d-3e66-4363-8c63-289048e2c5b8 |
| 5 | 658620095 | ANDA | Aurobindo Pharma Limited | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065370 | c36f2137-98bb-4583-89f7-6bce9582c465 |
cefpodoxime 200 mg oral tablet
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 007815439 | ANDA | Sandoz Inc | 2008-05-28 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065462 | 8519a9d8-7106-4545-bc58-859ee9a6708e |
| 2 | 167140395 | ANDA | Northstar Rx Llc | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065370 | 4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9 |
| 3 | 266370712 | ANDA | Putney, Inc. | 2008-05-28 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065462 | 91f2a366-97f3-4372-9803-f0e8afe89089 |
| 4 | 523430020 | ANDA | Lucid Pharma Llc | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065370 | 6a0f198d-3e66-4363-8c63-289048e2c5b8 |
| 5 | 658620096 | ANDA | Aurobindo Pharma Limited | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | ANDA065370 | c36f2137-98bb-4583-89f7-6bce9582c465 |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 552890393 | ANDA | Pd-Rx Pharmaceuticals, Inc. | 2007-06-11 | CEFPODOXIME PROXETIL | ORAL | TABLET, FILM COATED | 658620096 | ANDA065370 | 8b7f7043-5bfb-47a5-80cb-4f3f65358dff |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug |
|---|---|---|---|---|---|---|
| 1 | ANDA065083 | CEFPODOXIME PROXETIL | SUN PHARMACEUTICAL INDUSTRIES LTD | 2003-08-20 | ANDA065083_001, ANDA065083_002 | |
| 2 | ANDA065370 | CEFPODOXIME PROXETIL | AUROBINDO PHARMA LTD | 2007-06-11 | ANDA065370_001, ANDA065370_002 | |
| 3 | ANDA065388 | CEFPODOXIME PROXETIL | ORCHID HEALTHCARE | 2007-11-14 | ANDA065388_001, ANDA065388_002 | |
| 4 | ANDA065462 | CEFPODOXIME PROXETIL | SANDOZ INC | 2008-05-28 | ANDA065462_001, ANDA065462_002 | |
| 5 | NDA050674 | VANTIN | True | PHARMACIA AND UPJOHN CO | 1992-08-07 | NDA050674_001, NDA050674_002 |
| 6 | NDA050687 | BANAN | True | SANKYO USA CORP | 1992-08-07 | NDA050687_001, NDA050687_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA065083_001 | RX | CEFPODOXIME PROXETIL (EQ 100MG BASE) | ORAL | TABLET | False | AB | 2003-08-20 | CEFPODOXIME PROXETIL |
| 2 | ANDA065083_002 | RX | CEFPODOXIME PROXETIL (EQ 200MG BASE) | ORAL | TABLET | False | AB | 2003-08-20 | CEFPODOXIME PROXETIL |
| 3 | ANDA065370_001 | RX | CEFPODOXIME PROXETIL (EQ 100MG BASE) | ORAL | TABLET | False | AB | 2007-06-11 | CEFPODOXIME PROXETIL |
| 4 | ANDA065370_002 | RX | CEFPODOXIME PROXETIL (EQ 200MG BASE) | ORAL | TABLET | False | AB | 2007-06-11 | CEFPODOXIME PROXETIL |
| 5 | ANDA065388_001 | RX | CEFPODOXIME PROXETIL (EQ 100MG BASE) | ORAL | TABLET | False | AB | 2007-11-14 | CEFPODOXIME PROXETIL |
| 6 | ANDA065388_002 | RX | CEFPODOXIME PROXETIL (EQ 200MG BASE) | ORAL | TABLET | False | AB | 2007-11-14 | CEFPODOXIME PROXETIL |
| 7 | ANDA065462_001 | RX | CEFPODOXIME PROXETIL (EQ 100MG BASE) | ORAL | TABLET | False | AB | 2008-05-28 | CEFPODOXIME PROXETIL |
| 8 | ANDA065462_002 | RX | CEFPODOXIME PROXETIL (EQ 200MG BASE) | ORAL | TABLET | True | AB | 2008-05-28 | CEFPODOXIME PROXETIL |
| 9 | NDA050674_001 | discontinued | CEFPODOXIME PROXETIL (EQ 100MG BASE) | ORAL | TABLET | False | 1992-08-07 | VANTIN | |
| 10 | NDA050674_002 | discontinued | CEFPODOXIME PROXETIL (EQ 200MG BASE) | ORAL | TABLET | False | 1992-08-07 | VANTIN | |
| 11 | NDA050687_001 | discontinued | CEFPODOXIME PROXETIL (EQ 100MG BASE) | ORAL | TABLET | False | 1992-08-07 | BANAN | |
| 12 | NDA050687_002 | discontinued | CEFPODOXIME PROXETIL (EQ 200MG BASE) | ORAL | TABLET | False | 1992-08-07 | BANAN |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9 (view SPL) | prescription | Human Prescription | Northstar Rx Llc | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2013-10-01 | 2 | 167140394, 167140395 | |
| 2 | 6a0f198d-3e66-4363-8c63-289048e2c5b8 (view SPL) | Cefpodoxime Proxetil Tablets, USPRx only | prescription | Human Prescription | Lucid Pharma Llc | 2014-04-08 | 3 | 523430019, 523430020 | |
| 3 | 8519a9d8-7106-4545-bc58-859ee9a6708e (view SPL) | Cefpodoxime Proxetil Tablets, USP | prescription | Human Prescription | Sandoz Inc | 2014-07-28 | 14 | 007815438, 007815439 | |
| 4 | 8b7f7043-5bfb-47a5-80cb-4f3f65358dff (view SPL) | Cefpodoxime Proxetil Tablets, USP | prescription | Human Prescription | Pd-Rx Pharmaceuticals, Inc. | repack | 2010-06-23 | 3 | 552890393 |
| 5 | 91f2a366-97f3-4372-9803-f0e8afe89089 (view SPL) | Cefpodoxime Proxetil Tablets, USP | prescription | Human Prescription | Putney, Inc. | 2014-09-23 | 12 | 266370711, 266370712 | |
| 6 | c36f2137-98bb-4583-89f7-6bce9582c465 (view SPL) | Cefpodoxime Proxetil Tablets, USP | prescription | Human Prescription | Aurobindo Pharma Limited | ANALYSIS, API MANUFACTURE, MANUFACTURE | 2013-07-30 | 5 | 658620095, 658620096 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII