FDA — authorised 23 May 2002
- Application: ANDA075866
- Marketing authorisation holder: BARR
- Status: supplemented
🇺🇸 Portia in United States
FDA authorised Portia on 23 May 2002
Marketing authorisations
FDA — authorised 29 April 2003
- Application: ANDA075862
- Marketing authorisation holder: BARR
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 31 May 2006
- Application: ANDA077681
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 6 June 2011
- Application: ANDA079218
- Marketing authorisation holder: WATSON LABS
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 October 2012
- Application: ANDA091440
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 2013
- Application: ANDA091425
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 8 December 2014
- Application: ANDA202247
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 12 June 2015
- Application: ANDA203164
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2018
- Application: ANDA202970
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 17 August 2020
- Application: ANDA207065
- Marketing authorisation holder: NAARI PTE
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA
- Status: approved
Portia 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 Portia approved in United States?
Yes. FDA authorised it on 23 May 2002; FDA authorised it on 29 April 2003; FDA authorised it on 31 May 2006.
Who is the marketing authorisation holder for Portia in United States?
BARR holds the US marketing authorisation.