FDA — authorised 12 December 1980
- Application: NDA018555
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: YUTOPAR
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Ritodrine Oral Tablet on 12 December 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 12 December 1980; FDA has authorised it; FDA has authorised it.
ASTRAZENECA holds the US marketing authorisation.