🇺🇸 Estradiol/norethindrone acetate in United States

FDA authorised Estradiol/norethindrone acetate on 7 August 1998 · 857 US adverse-event reports

Marketing authorisations

FDA — authorised 7 August 1998

  • Application: NDA020870
  • Marketing authorisation holder: NOVEN PHARMS INC
  • Status: supplemented

FDA — authorised 11 April 2000

  • Application: NDA021103
  • Marketing authorisation holder: NOVO NORDISK
  • Local brand name: ACTIVELLA
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 April 2008

  • Application: ANDA078324
  • Marketing authorisation holder: BRECKENRIDGE PHARM
  • Status: supplemented

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.

Most-reported reactions

  1. Nausea — 119 reports (13.89%)
  2. Headache — 116 reports (13.54%)
  3. Fatigue — 110 reports (12.84%)
  4. Dizziness — 100 reports (11.67%)
  5. Pruritus — 76 reports (8.87%)
  6. Arthralgia — 74 reports (8.63%)
  7. Migraine — 68 reports (7.93%)
  8. Diarrhoea — 67 reports (7.82%)
  9. Off Label Use — 66 reports (7.7%)
  10. Abdominal Pain — 61 reports (7.12%)

Source database →

Other Women's Health / Endocrinology approved in United States

Frequently asked questions

Is Estradiol/norethindrone acetate approved in United States?

Yes. FDA authorised it on 7 August 1998; FDA authorised it on 11 April 2000; FDA authorised it on 17 April 2008.

Who is the marketing authorisation holder for Estradiol/norethindrone acetate in United States?

NOVEN PHARMS INC holds the US marketing authorisation.