🇺🇸 Ethinyl estradiol and norelgestromin in United States

FDA authorised Ethinyl estradiol and norelgestromin on 20 November 2001 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 20 November 2001

  • Application: NDA021180
  • Marketing authorisation holder: JANSSEN PHARMS
  • Local brand name: ORTHO EVRA
  • Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
  • Status: approved

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FDA — authorised 25 February 2021

  • Application: ANDA213950
  • Marketing authorisation holder: AMNEAL
  • Local brand name: ETHINYL ESTRADIOL AND NORELGESTROMIN
  • Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
  • Status: approved

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FDA — authorised 14 September 2023

  • Application: ANDA214594
  • Marketing authorisation holder: ZYDUS PHARMS
  • Local brand name: ETHINYL ESTRADIOL AND NORELGESTROMIN
  • Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
  • Status: approved

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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.

Most-reported reactions

  1. Activities Of Daily Living Impaired — 1 report (10%)
  2. Anaemia — 1 report (10%)
  3. Emotional Disorder — 1 report (10%)
  4. Feeling Abnormal — 1 report (10%)
  5. Feeling Drunk — 1 report (10%)
  6. Fibromyalgia — 1 report (10%)
  7. Gait Disturbance — 1 report (10%)
  8. Hunger — 1 report (10%)
  9. Impaired Driving Ability — 1 report (10%)
  10. Muscle Spasms — 1 report (10%)

Source database →

Ethinyl estradiol and norelgestromin 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 Ethinyl estradiol and norelgestromin approved in United States?

Yes. FDA authorised it on 20 November 2001; FDA authorised it on 25 February 2021; FDA authorised it on 14 September 2023.

Who is the marketing authorisation holder for Ethinyl estradiol and norelgestromin in United States?

JANSSEN PHARMS holds the US marketing authorisation.