🇺🇸 Loestrin in United States

FDA authorised Loestrin on 30 May 2003

Marketing authorisations

FDA — authorised 30 May 2003

  • Application: ANDA076380
  • Marketing authorisation holder: BARR LABS
  • Status: supplemented

FDA — authorised 30 May 2003

  • Application: ANDA076381
  • Marketing authorisation holder: BARR
  • Status: supplemented

FDA — authorised 18 September 2003

  • Application: ANDA076081
  • Marketing authorisation holder: BARR
  • Status: supplemented

FDA — authorised 18 September 2003

  • Application: ANDA076064
  • Marketing authorisation holder: BARR
  • Status: supplemented

FDA — authorised 21 October 2010

  • Application: NDA022501
  • Marketing authorisation holder: APIL
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Loestrin approved in United States?

Yes. FDA authorised it on 30 May 2003; FDA authorised it on 30 May 2003; FDA authorised it on 18 September 2003.

Who is the marketing authorisation holder for Loestrin in United States?

BARR LABS holds the US marketing authorisation.