FDA — authorised 21 April 1982
- Application: NDA018405
- Marketing authorisation holder: DURAMED RES
- Local brand name: AYGESTIN
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Norethindrone acetate pretreatment on 21 April 1982
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 21 April 1982; FDA has authorised it.
DURAMED RES holds the US marketing authorisation.