FDA — authorised 30 July 1980
- Application: ANDA062291
- Marketing authorisation holder: SANDOZ
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Cefadrox in United States
FDA authorised Cefadrox on 30 July 1980
Marketing authorisations
FDA — authorised 3 March 1987
- Application: ANDA062766
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 April 1987
- Application: ANDA062774
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CEFADROXIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 1989
- Application: ANDA063017
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 February 1989
- Application: ANDA062695
- Marketing authorisation holder: TEVA
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 March 1989
- Application: ANDA062698
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 April 1999
- Application: ANDA065018
- Marketing authorisation holder: RANBAXY
- Local brand name: CEFADROXIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 1999
- Application: ANDA065015
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 March 2003
- Application: ANDA065115
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 January 2006
- Application: ANDA065278
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 January 2006
- Application: ANDA065282
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 February 2006
- Application: ANDA065311
- Marketing authorisation holder: HIKMA
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 March 2006
- Application: ANDA065260
- Marketing authorisation holder: HIKMA
- Local brand name: CEFADROXIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2006
- Application: ANDA065301
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFADROXIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2006
- Application: ANDA065309
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 October 2006
- Application: ANDA065307
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 January 2007
- Application: ANDA065352
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 May 2007
- Application: ANDA065392
- Marketing authorisation holder: LUPIN
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 February 2008
- Application: ANDA065396
- Marketing authorisation holder: LUPIN
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 November 2012
- Application: ANDA091036
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 April 2013
- Application: ANDA065349
- Marketing authorisation holder: AUROBINDO
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 July 2017
- Application: ANDA205072
- Marketing authorisation holder: CSPC OUYI
- Local brand name: CEFADROXIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062334
- Marketing authorisation holder: APOTHECON
- Local brand name: CEFADROXIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Cefadrox 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 Cefadrox approved in United States?
Yes. FDA authorised it on 30 July 1980; FDA authorised it on 3 March 1987; FDA authorised it on 8 April 1987.
Who is the marketing authorisation holder for Cefadrox in United States?
SANDOZ holds the US marketing authorisation.