FDA — authorised 19 November 1980
- Application: NDA018261
- Marketing authorisation holder: PH HEALTH
- Local brand name: PITOCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Intranasal Oxytocin on 19 November 1980
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 19 November 1980; FDA has authorised it.
PH HEALTH holds the US marketing authorisation.