FDA — authorised 10 December 1990
- Application: NDA019976
- Marketing authorisation holder: FRESENIUS MEDCL CARE
- Local brand name: PHOSLO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Phoslo in United States
FDA authorised Phoslo on 10 December 1990
Marketing authorisations
FDA — authorised 2 April 2001
- Application: NDA021160
- Marketing authorisation holder: FRESENIUS MEDCL CARE
- Local brand name: PHOSLO
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 February 2013
- Application: ANDA202420
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Status: approved
FDA — authorised 7 February 2013
- Application: ANDA203135
- Marketing authorisation holder: INVAGEN PHARMS
- Status: approved
FDA — authorised 29 June 2015
- Application: ANDA202315
- Marketing authorisation holder: HERITAGE PHARMS INC
- Status: approved
FDA — authorised 20 November 2018
- Application: ANDA091312
- Marketing authorisation holder: CHARTWELL RX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 March 2023
- Application: ANDA217205
- Marketing authorisation holder: SQUARE PHARMS
- Status: approved
Phoslo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Phoslo approved in United States?
Yes. FDA authorised it on 10 December 1990; FDA authorised it on 2 April 2001; FDA authorised it on 5 February 2013.
Who is the marketing authorisation holder for Phoslo in United States?
FRESENIUS MEDCL CARE holds the US marketing authorisation.