🇺🇸 Phase 3 NOMAC-E2 "Batch A" in United States

FDA authorised Phase 3 NOMAC-E2 "Batch A" on 1 October 2004

Marketing authorisations

FDA — authorised 1 October 2004

  • Application: NDA021735
  • Marketing authorisation holder: FOUGERA PHARMS INC
  • Status: supplemented

FDA — authorised 14 October 2009

  • Application: ANDA078418
  • Marketing authorisation holder: STRIDES PHARMA
  • Status: supplemented

FDA — authorised 10 November 2010

  • Application: BLA022505
  • Marketing authorisation holder: THERATECHNOLOGIES
  • Status: supplemented

FDA — authorised 15 September 2020

  • Application: ANDA205360
  • Marketing authorisation holder: AVET
  • Status: approved

FDA — authorised 29 August 2023

  • Application: ANDA212634
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • Status: approved

Other Contraception / Gynecology approved in United States

Frequently asked questions

Is Phase 3 NOMAC-E2 "Batch A" approved in United States?

Yes. FDA authorised it on 1 October 2004; FDA authorised it on 14 October 2009; FDA authorised it on 10 November 2010.

Who is the marketing authorisation holder for Phase 3 NOMAC-E2 "Batch A" in United States?

FOUGERA PHARMS INC holds the US marketing authorisation.