FDA — authorised 26 December 1990
- Marketing authorisation holder: ABBOTT
- Status: approved
🇺🇸 Prosom in United States
FDA authorised Prosom on 26 December 1990
Marketing authorisations
FDA — authorised 26 December 1990
- Application: NDA019080
- Marketing authorisation holder: ABBOTT
- Local brand name: PROSOM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 1997
- Application: ANDA074826
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: ESTAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 1997
- Application: ANDA074921
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: ESTAZOLAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1997
- Application: ANDA074818
- Marketing authorisation holder: WATSON LABS
- Local brand name: ESTAZOLAM
- Indication: TABLET — ORAL
- Status: approved
Prosom 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 Prosom approved in United States?
Yes. FDA authorised it on 26 December 1990; FDA authorised it on 26 December 1990; FDA authorised it on 3 July 1997.
Who is the marketing authorisation holder for Prosom in United States?
ABBOTT holds the US marketing authorisation.