FDA — authorised 7 August 1992
- Application: NDA050688
- Marketing authorisation holder: SANKYO
- Local brand name: BANAN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Vantin in United States
FDA authorised Vantin on 7 August 1992
Marketing authorisations
FDA — authorised 7 August 1992
- Application: NDA050674
- Marketing authorisation holder: PFIZER
- Local brand name: VANTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 August 1992
- Application: NDA050675
- Marketing authorisation holder: PFIZER
- Local brand name: VANTIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 7 August 1992
- Application: NDA050687
- Marketing authorisation holder: SANKYO
- Local brand name: BANAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2002
- Application: ANDA065082
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEFPODOXIME PROXETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 August 2003
- Application: ANDA065083
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEFPODOXIME PROXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 2007
- Application: ANDA065409
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CEFPODOXIME PROXETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 June 2007
- Application: ANDA065370
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFPODOXIME PROXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2007
- Application: ANDA065388
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEFPODOXIME PROXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2009
- Application: ANDA090031
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFPODOXIME PROXETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 February 2014
- Application: ANDA065462
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 18 May 2022
- Application: ANDA210568
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEFPODOXIME PROXETIL
- Indication: TABLET — ORAL
- Status: approved
Vantin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Vantin approved in United States?
Yes. FDA authorised it on 7 August 1992; FDA authorised it on 7 August 1992; FDA authorised it on 7 August 1992.
Who is the marketing authorisation holder for Vantin in United States?
SANKYO holds the US marketing authorisation.