FDA — authorised 23 December 1991
- Application: NDA050665
- Marketing authorisation holder: CORDEN PHARMA
- Local brand name: CEFZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Cefzil in United States
FDA authorised Cefzil on 23 December 1991
Marketing authorisations
FDA — authorised 23 December 1991
- Application: NDA050664
- Marketing authorisation holder: CORDEN PHARMA
- Local brand name: CEFZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1991
- Status: approved
FDA — authorised 14 November 2005
- Application: ANDA065235
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2005
- Application: ANDA065257
- Marketing authorisation holder: SANDOZ
- Local brand name: CEFPROZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 December 2005
- Application: ANDA065236
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFPROZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 December 2005
- Application: ANDA065276
- Marketing authorisation holder: LUPIN
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 2005
- Application: ANDA065261
- Marketing authorisation holder: LUPIN
- Local brand name: CEFPROZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 December 2005
- Application: ANDA065267
- Marketing authorisation holder: ORCHID HLTHCARE
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2005
- Application: ANDA065284
- Marketing authorisation holder: ORCHID HLTHCARE
- Local brand name: CEFPROZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 January 2007
- Application: ANDA065381
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFPROZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 May 2007
- Application: ANDA065340
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2007
- Application: ANDA065428
- Marketing authorisation holder: WOCKHARDT
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2008
- Application: ANDA065208
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 26 March 2008
- Application: ANDA065327
- Marketing authorisation holder: APOTEX INC
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 February 2012
- Application: ANDA065351
- Marketing authorisation holder: APOTEX INC
- Local brand name: CEFPROZIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 April 2024
- Application: ANDA090857
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEFPROZIL
- Indication: TABLET — ORAL
- Status: approved
Cefzil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Cefzil approved in United States?
Yes. FDA authorised it on 23 December 1991; FDA authorised it on 23 December 1991; FDA authorised it on 23 December 1991.
Who is the marketing authorisation holder for Cefzil in United States?
CORDEN PHARMA holds the US marketing authorisation.