FDA — authorised 17 August 1987
- Application: NDA019398
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Labeling
- Status: approved
🇺🇸 Procalamine in United States
FDA authorised Procalamine on 17 August 1987
Marketing authorisations
FDA — authorised 7 September 1988
- Application: NDA019018
- Marketing authorisation holder: B BRAUN
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 July 1994
- Application: NDA020015
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 August 2002
- Application: NDA020041
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Labeling
- Status: approved
FDA — authorised 25 January 2015
- Application: ANDA091112
- Marketing authorisation holder: B BRAUN
- Indication: Labeling
- Status: approved
FDA
- Status: approved
Procalamine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Procalamine approved in United States?
Yes. FDA authorised it on 17 August 1987; FDA authorised it on 7 September 1988; FDA authorised it on 11 July 1994.
Who is the marketing authorisation holder for Procalamine in United States?
OTSUKA ICU MEDCL holds the US marketing authorisation.