FDA — authorised 29 April 2003
- Application: ANDA075862
- Marketing authorisation holder: BARR
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
🇺🇸 levonorgestrel and ethinyl estradiol in United States
FDA authorised levonorgestrel and ethinyl estradiol on 29 April 2003 · 333 US adverse-event reports
Marketing authorisations
FDA — authorised 18 November 2004
- Application: ANDA076625
- Marketing authorisation holder: DR REDDYS LABS SA
- 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 26 October 2011
- Application: ANDA091674
- Marketing authorisation holder: LUPIN LTD
- Status: supplemented
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 21 December 2012
- Application: ANDA091663
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- 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 9 October 2013
- Application: ANDA200245
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 5 February 2014
- Application: ANDA201108
- Marketing authorisation holder: AMNEAL PHARMS
- 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 8 December 2014
- Application: ANDA201095
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA — authorised 21 April 2015
- Application: ANDA200490
- Marketing authorisation holder: XIROMED
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL
- 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 17 June 2015
- Application: ANDA200493
- Marketing authorisation holder: XIROMED
- Status: supplemented
FDA — authorised 19 November 2015
- Application: ANDA200248
- Marketing authorisation holder: LUPIN
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- 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 — authorised 9 October 2020
- Application: ANDA207033
- Marketing authorisation holder: NAARI PTE
- Status: approved
FDA — authorised 13 February 2023
- Application: ANDA212298
- Marketing authorisation holder: HETERO LABS
- Local brand name: LEVONORGESTREL AND ETHINYL ESTRADIOL
- Indication: TABLET — ORAL-28
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 333
Most-reported reactions
- Nausea — 52 reports (15.62%)
- Headache — 39 reports (11.71%)
- Vomiting — 35 reports (10.51%)
- Fatigue — 33 reports (9.91%)
- Drug Ineffective — 32 reports (9.61%)
- Dizziness — 31 reports (9.31%)
- Pulmonary Embolism — 30 reports (9.01%)
- Metrorrhagia — 29 reports (8.71%)
- Anxiety — 26 reports (7.81%)
- Diarrhoea — 26 reports (7.81%)
levonorgestrel and ethinyl estradiol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is levonorgestrel and ethinyl estradiol approved in United States?
Yes. FDA authorised it on 29 April 2003; FDA authorised it on 18 November 2004; FDA authorised it on 31 May 2006.
Who is the marketing authorisation holder for levonorgestrel and ethinyl estradiol in United States?
BARR holds the US marketing authorisation.