FDA Orange Book · active-ingredient family
Cefpodoxime proxetil
Cefpodoxime proxetil is approved as 4 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VANTIN · NDA 050675
4
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VANTINRLD×2 | PFIZER | NDA 050675 | — | Aug 07, 1992 | |
| VANTINRLD×2 | PFIZER | NDA 050674 | — | Aug 07, 1992 | |
| BANAN×2 | SANKYO | NDA 050688 | — | Aug 07, 1992 | |
| BANAN×2 | SANKYO | NDA 050687 | — | Aug 07, 1992 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFPODOXIME PROXETIL×2 | ALKEM LABS LTD | ANDA 210568 | AB | May 18, 2022 | |
| CEFPODOXIME PROXETIL×2 | CHARTWELL RX | ANDA 090031 | — | Jan 14, 2009 | |
| CEFPODOXIME PROXETIL×2 | SANDOZ | ANDA 065462 | AB | May 28, 2008 | |
| CEFPODOXIME PROXETIL×2 | ANDA REPOSITORY | ANDA 065388 | AB | Nov 14, 2007 | |
| CEFPODOXIME PROXETIL×2 | AUROBINDO PHARMA | ANDA 065370 | AB | Jun 11, 2007 | |
| CEFPODOXIME PROXETIL×2 | AUROBINDO PHARMA LTD | ANDA 065409 | — | Jun 08, 2007 | |
| CEFPODOXIME PROXETIL×2 | SUN PHARM INDS LTD | ANDA 065083 | — | Aug 20, 2003 | |
| CEFPODOXIME PROXETIL×2 | SUN PHARM INDS LTD | ANDA 065082 | — | May 31, 2002 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Cefpodoxime proxetil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
