FDA — authorised 12 October 1972
- Application: NDA050440
- Marketing authorisation holder: LILLY
- Local brand name: KEFLET
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 keflex in United States
FDA authorised keflex on 12 October 1972
Marketing authorisations
FDA — authorised 26 April 1976
- Application: ANDA061969
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 1978
- Application: ANDA062117
- Marketing authorisation holder: FACTA FARMA
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 March 1978
- Application: ANDA062118
- Marketing authorisation holder: FACTA FARMA
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 December 1986
- Application: ANDA062745
- Marketing authorisation holder: LILLY
- Local brand name: KEFLET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 1987
- Application: ANDA062702
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 February 1987
- Application: ANDA062703
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 April 1987
- Application: ANDA062775
- Marketing authorisation holder: BARR
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 1987
- Application: ANDA062760
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 1987
- Application: ANDA062761
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 June 1987
- Application: ANDA062768
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 June 1987
- Application: ANDA062767
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 June 1987
- Application: ANDA062773
- Marketing authorisation holder: BARR
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 August 1987
- Application: ANDA062777
- Marketing authorisation holder: BARR
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 August 1987
- Application: ANDA062778
- Marketing authorisation holder: BARR
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 March 1988
- Application: ANDA062869
- Marketing authorisation holder: STEVENS J
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 March 1988
- Application: ANDA062870
- Marketing authorisation holder: STEVENS J
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 June 1988
- Application: ANDA062872
- Marketing authorisation holder: YOSHITOMI
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 July 1988
- Application: ANDA062871
- Marketing authorisation holder: YOSHITOMI
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 July 1988
- Application: ANDA062713
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 January 1989
- Application: ANDA062781
- Marketing authorisation holder: VITARINE
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 January 1989
- Application: ANDA063024
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 1989
- Application: ANDA062779
- Marketing authorisation holder: VITARINE
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 July 1989
- Application: ANDA062987
- Marketing authorisation holder: APOTHECON
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 September 1989
- Application: ANDA063063
- Marketing authorisation holder: APOTHECON
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 1991
- Application: ANDA062986
- Marketing authorisation holder: APOTHECON
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 December 1994
- Application: ANDA063186
- Marketing authorisation holder: APOTHECON
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 September 1999
- Application: ANDA065007
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 July 2001
- Application: ANDA065081
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 September 2003
- Application: ANDA065100
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: PANIXINE DISPERDOSE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 February 2005
- Application: ANDA065152
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 2005
- Application: ANDA065248
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 August 2005
- Application: ANDA065234
- Marketing authorisation holder: LUPIN
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 November 2005
- Application: ANDA065253
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 November 2005
- Application: ANDA065229
- Marketing authorisation holder: LUPIN
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 July 2006
- Application: ANDA065326
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 July 2007
- Application: ANDA065336
- Marketing authorisation holder: YUNG SHIN PHARM
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 August 2009
- Application: ANDA065444
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 December 2010
- Application: ANDA090836
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA210221
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 September 2024
- Application: ANDA218947
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEPHALEXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2024
- Application: ANDA218817
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CEPHALEXIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062863
- Marketing authorisation holder: VITARINE
- Local brand name: CEPHALEXIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA062974
- Marketing authorisation holder: APOTHECON
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062873
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062973
- Marketing authorisation holder: APOTHECON
- Local brand name: CEPHALEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA062867
- Marketing authorisation holder: TEVA
- Local brand name: CEPHALEXIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is keflex approved in United States?
Yes. FDA authorised it on 12 October 1972; FDA authorised it on 26 April 1976; FDA authorised it on 27 March 1978.
Who is the marketing authorisation holder for keflex in United States?
LILLY holds the US marketing authorisation.