FDA — authorised 30 April 1974
- Application: NDA017506
- Marketing authorisation holder: GE HEALTHCARE
- Local brand name: ISOPAQUE 280
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Calcium Acetate in United States
FDA authorised Calcium Acetate on 30 April 1974
Marketing authorisations
FDA — authorised 28 February 1984
- Application: NDA018494
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 February 1996
- Application: NDA018883
- Marketing authorisation holder: FRESENIUS MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 31 May 1996
- Application: ANDA089384
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 2 April 2001
- Application: NDA021160
- Marketing authorisation holder: FRESENIUS MEDCL CARE
- Local brand name: PHOSLO GELCAPS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 January 2008
- Application: ANDA077693
- Marketing authorisation holder: HIKMA
- Local brand name: CALCIUM ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2008
- Application: ANDA077728
- Marketing authorisation holder: HIKMA
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 November 2008
- Application: ANDA078502
- Marketing authorisation holder: CYPRESS PHARM
- Local brand name: ELIPHOS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 2011
- Application: ANDA091561
- Marketing authorisation holder: PADAGIS US
- Local brand name: CALCIUM ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 2012
- Application: ANDA091312
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 October 2014
- Application: ANDA201658
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 January 2015
- Application: ANDA202885
- Marketing authorisation holder: HERITAGE PHARMS INC
- Local brand name: CALCIUM ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 2015
- Application: ANDA202315
- Marketing authorisation holder: HERITAGE PHARMS INC
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 July 2015
- Application: ANDA202127
- Marketing authorisation holder: LUPIN
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 October 2015
- Application: ANDA203179
- Marketing authorisation holder: MPP PHARMA
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 July 2016
- Application: ANDA203298
- Marketing authorisation holder: LOTUS PHARM CO LTD
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 July 2018
- Application: ANDA207226
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 21 February 2020
- Application: ANDA211038
- Marketing authorisation holder: SUVEN PHARMS
- Local brand name: CALCIUM ACETATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 June 2024
- Application: ANDA206047
- Marketing authorisation holder: ZYDUS PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Calcium Acetate for the treatment of patients with chronic kidney disease (CKD) on dialysis. This approval was granted to ZYDUS PHARMS, the marketing authorisation holder, on 11 June 2024, under application number ANDA206047. The approval was made through the standard expedited pathway.
FDA
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
Calcium Acetate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Calcium Acetate approved in United States?
Yes. FDA authorised it on 30 April 1974; FDA authorised it on 28 February 1984; FDA authorised it on 22 February 1996.
Who is the marketing authorisation holder for Calcium Acetate in United States?
GE HEALTHCARE holds the US marketing authorisation.