FDA — authorised 28 December 1987
- Application: NDA050605
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: CEFTIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ceftin in United States
FDA authorised Ceftin on 28 December 1987
Marketing authorisations
FDA — authorised 30 June 1994
- Application: NDA050672
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: CEFTIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 February 2002
- Application: ANDA065043
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2002
- Application: ANDA065069
- Marketing authorisation holder: APOTEX
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 April 2003
- Application: ANDA065118
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2003
- Application: ANDA065135
- Marketing authorisation holder: LUPIN
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2003
- Application: ANDA065126
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2005
- Application: ANDA065166
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2006
- Application: ANDA065308
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2008
- Application: ANDA065323
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEFUROXIME AXETIL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 February 2008
- Application: ANDA065359
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEFUROXIME AXETIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2017
- Application: ANDA065496
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
Ceftin 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 Ceftin approved in United States?
Yes. FDA authorised it on 28 December 1987; FDA authorised it on 30 June 1994; FDA authorised it on 15 February 2002.
Who is the marketing authorisation holder for Ceftin in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.