FDA — authorised 28 December 1984
- Application: NDA018917
- Marketing authorisation holder: PROMIUS PHARMA
- Local brand name: SECTRAL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Sectral in United States
FDA authorised Sectral on 28 December 1984
Marketing authorisations
FDA — authorised 15 July 2002
- Application: ANDA074007
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 May 2007
- Application: ANDA075047
- Marketing authorisation holder: AMNEAL PHARM
- Indication: Manufacturing (CMC)
- Status: approved
Sectral in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Sectral approved in United States?
Yes. FDA authorised it on 28 December 1984; FDA authorised it on 15 July 2002; FDA authorised it on 22 May 2007.
Who is the marketing authorisation holder for Sectral in United States?
PROMIUS PHARMA holds the US marketing authorisation.