FDA — authorised 15 June 2017
- Application: NDA208418
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Calcium Gluconate in United States
FDA authorised Calcium Gluconate on 15 June 2017
Marketing authorisations
FDA — authorised 29 October 2018
- Application: NDA210906
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 14 October 2022
- Application: ANDA213071
- Marketing authorisation holder: NIVAGEN PHARMS INC
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA216541
- Marketing authorisation holder: B BRAUN MEDICAL
- Local brand name: CALCIUM GLUCONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 September 2023
- Application: ANDA217174
- Marketing authorisation holder: AMNEAL
- Local brand name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 19 October 2023
- Application: ANDA217689
- Marketing authorisation holder: SOMERSET
- Local brand name: CALCIUM GLUCONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA216611
- Marketing authorisation holder: AMNEAL
- Local brand name: CALCIUM GLUCONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 30 December 2025
- Application: ANDA219619
- Marketing authorisation holder: SAGENT
- Local brand name: CALCIUM GLUCONATE IN SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2026
- Application: ANDA218840
- Marketing authorisation holder: CAPLIN
- Local brand name: CALCIUM GLUCONATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved CAPLIN's application (ANDA218840) for Calcium Gluconate, a solution for intravenous use, on 4 May 2026. This approval allows CAPLIN to market Calcium Gluconate in the United States. The product is indicated for the treatment of hypocalcemia.
Calcium Gluconate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Calcium Gluconate approved in United States?
Yes. FDA authorised it on 15 June 2017; FDA authorised it on 29 October 2018; FDA authorised it on 14 October 2022.
Who is the marketing authorisation holder for Calcium Gluconate in United States?
FRESENIUS KABI USA holds the US marketing authorisation.