FDA — authorised 10 December 1992
- Marketing authorisation holder: ORGANON USA INC
- Status: approved
🇺🇸 Ortho-Cept in United States
FDA authorised Ortho-Cept on 10 December 1992
Marketing authorisations
FDA — authorised 14 December 1992
- Application: NDA020301
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: ORTHO-CEPT
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 12 August 1999
- Application: ANDA075256
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-21
- Status: approved
FDA — authorised 20 December 2000
- Application: NDA021090
- Marketing authorisation holder: ASPEN GLOBAL INC
- Local brand name: CYCLESSA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 24 February 2004
- Application: ANDA076455
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: DESOGESTREL; ETHINYL
- Indication: Tablet — Oral
- Status: approved
FDA — authorised 29 July 2005
- Application: ANDA076915
- Marketing authorisation holder: WATSON LABS
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 24 January 2006
- Application: ANDA077182
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA076916
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 25 February 2011
- Application: ANDA076675
- Marketing authorisation holder: PH HEALTH
- Local brand name: EMOQUETTE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 2 April 2012
- Application: ANDA091346
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: VIORELE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 7 March 2013
- Application: ANDA201887
- Marketing authorisation holder: LUPIN LTD
- Local brand name: ENSKYCE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 12 July 2013
- Application: ANDA091234
- Marketing authorisation holder: NOVAST LABS
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 1 August 2013
- Application: ANDA091247
- Marketing authorisation holder: NOVAST LABS
- Local brand name: PIMTREA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 August 2013
- Application: ANDA202296
- Marketing authorisation holder: XIROMED
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 30 April 2015
- Application: ANDA076681
- Marketing authorisation holder: PH HEALTH
- Local brand name: KIMIDESS
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 12 August 2015
- Application: ANDA202226
- Marketing authorisation holder: LUPIN
- Local brand name: BEKYREE
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 9 September 2016
- Application: ANDA202689
- Marketing authorisation holder: XIROMED
- Local brand name: VOLNEA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 22 March 2017
- Application: ANDA206853
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SIMLIYA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 May 2017
- Application: ANDA207081
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: KALLIGA
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA209170
- Marketing authorisation holder: NAARI PTE
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 9 August 2017
- Application: ANDA202789
- Marketing authorisation holder: XIROMED
- Indication: Labeling
- Status: approved
FDA — authorised 13 September 2018
- Application: ANDA207067
- Marketing authorisation holder: NAARI PTE
- Local brand name: DESOGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA218933
- Marketing authorisation holder: AVION PHARMS
- Local brand name: AVERI
- Indication: TABLET — ORAL-21
- Status: approved
Ortho-Cept in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ortho-Cept approved in United States?
Yes. FDA authorised it on 10 December 1992; FDA authorised it on 14 December 1992; FDA authorised it on 12 August 1999.
Who is the marketing authorisation holder for Ortho-Cept in United States?
ORGANON USA INC holds the US marketing authorisation.