FDA — authorised 21 October 1986
- Application: NDA018892
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Osmoprep in United States
FDA authorised Osmoprep on 21 October 1986
Marketing authorisations
FDA — authorised 22 February 1990
- Application: NDA019513
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 September 2000
- Marketing authorisation holder: SALIX PHARMS
- Status: approved
FDA — authorised 16 March 2006
- Application: NDA021892
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: OSMOPREP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2022
- Application: ANDA209997
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 21 June 2024
- Application: ANDA218314
- Marketing authorisation holder: AM REGENT
- Status: approved
Osmoprep in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Osmoprep approved in United States?
Yes. FDA authorised it on 21 October 1986; FDA authorised it on 22 February 1990; FDA authorised it on 21 September 2000.
Who is the marketing authorisation holder for Osmoprep in United States?
HOSPIRA holds the US marketing authorisation.