FDA — authorised 29 November 2007
- Application: ANDA065409
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
🇺🇸 Cefpodoxime Proxetil in United States
FDA authorised Cefpodoxime Proxetil on 29 November 2007
Marketing authorisations
FDA — authorised 5 February 2014
- Application: ANDA065462
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 21 September 2015
- Application: ANDA065370
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 18 May 2022
- Application: ANDA210568
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
Cefpodoxime Proxetil 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 Cefpodoxime Proxetil approved in United States?
Yes. FDA authorised it on 29 November 2007; FDA authorised it on 5 February 2014; FDA authorised it on 21 September 2015.
Who is the marketing authorisation holder for Cefpodoxime Proxetil in United States?
AUROBINDO PHARMA LTD holds the US marketing authorisation.