Orange Book product · Brand (NDA)
VANTIN
CEFPODOXIME PROXETIL
At a glance
Aug 07, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 1992
34 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CEFPODOXIME PROXETIL
Strength
EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 050674
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1992BANANBrand (NDA)
NDA 050688 · SANKYO
- 1992VANTINBrand (NDA)
NDA 050675 · PFIZER
- 1992BANANBrand (NDA)
NDA 050687 · SANKYO
- 2022CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 210568 · ALKEM LABS LTD
- 2009CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 090031 · CHARTWELL RX
- 2008CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 065462 · SANDOZ
- 2007CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 065388 · ANDA REPOSITORY
- 2007CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 065370 · AUROBINDO PHARMA
- 2007CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 065409 · AUROBINDO PHARMA LTD
- 2003CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 065083 · SUN PHARM INDS LTD
- 2002CEFPODOXIME PROXETILGeneric (ANDA)
ANDA 065082 · SUN PHARM INDS LTD
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.
