FDA — authorised 30 April 1973
- Marketing authorisation holder: WARNER CHILCOTT LLC
- Status: approved
🇺🇸 Aygestin in United States
FDA authorised Aygestin on 30 April 1973
Marketing authorisations
FDA — authorised 21 April 1982
- Application: NDA018405
- Marketing authorisation holder: DURAMED RES
- Local brand name: AYGESTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 May 2001
- Application: ANDA075951
- Marketing authorisation holder: BARR
- Local brand name: NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2010
- Application: ANDA091090
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 July 2012
- Application: ANDA200275
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 2016
- Application: ANDA204236
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 November 2016
- Application: ANDA205278
- Marketing authorisation holder: XIROMED
- Local brand name: NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 2018
- Application: ANDA206490
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: NORETHINDRONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2022
- Application: ANDA204847
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 13 June 2024
- Application: ANDA213317
- Marketing authorisation holder: XIROMED
- Indication: Labeling
- Status: approved
The FDA approved Aygestin for marketing in the United States on 13 June 2024. XIROMED is the marketing authorisation holder for the drug. The approval was granted under the standard expedited pathway.
FDA
- Application: ANDA208097
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA012184
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: NORLUTATE
- Indication: TABLET — ORAL
- Status: approved
Aygestin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Aygestin approved in United States?
Yes. FDA authorised it on 30 April 1973; FDA authorised it on 21 April 1982; FDA authorised it on 25 May 2001.
Who is the marketing authorisation holder for Aygestin in United States?
WARNER CHILCOTT LLC holds the US marketing authorisation.