FDA — authorised 4 December 1972
- Application: ANDA083159
- Marketing authorisation holder: ABBOTT
- Status: approved
🇺🇸 Multiple-Visit-"Calcium Hydroxide" in United States
FDA authorised Multiple-Visit-"Calcium Hydroxide" on 4 December 1972 · 751,002 US adverse-event reports
Marketing authorisations
FDA — authorised 30 April 1974
- Application: NDA017506
- Marketing authorisation holder: GE HEALTHCARE
- Status: supplemented
FDA — authorised 30 September 1980
- Application: NDA050480
- Marketing authorisation holder: PFIZER
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 May 1982
- Application: NDA018582
- Marketing authorisation holder: B BRAUN
- Status: supplemented
FDA — authorised 9 August 1983
- Application: NDA017710
- Marketing authorisation holder: DISTA
- Indication: Labeling
- Status: approved
FDA — authorised 10 June 1993
- Application: NDA019864
- Marketing authorisation holder: B BRAUN
- Status: supplemented
FDA — authorised 22 February 1996
- Application: NDA018883
- Marketing authorisation holder: FRESENIUS MEDCL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 19 July 2021
- Application: ANDA213361
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 18 February 2022
- Application: ANDA214623
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 751,002
Most-reported reactions
- Fatigue — 98,083 reports (13.06%)
- Nausea — 87,408 reports (11.64%)
- Drug Ineffective — 83,532 reports (11.12%)
- Diarrhoea — 81,018 reports (10.79%)
- Dyspnoea — 72,763 reports (9.69%)
- Pain — 72,027 reports (9.59%)
- Off Label Use — 70,772 reports (9.42%)
- Headache — 65,461 reports (8.72%)
- Arthralgia — 60,568 reports (8.06%)
- Dizziness — 59,370 reports (7.91%)
Multiple-Visit-"Calcium Hydroxide" in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Multiple-Visit-"Calcium Hydroxide" approved in United States?
Yes. FDA authorised it on 4 December 1972; FDA authorised it on 30 April 1974; FDA authorised it on 30 September 1980.
Who is the marketing authorisation holder for Multiple-Visit-"Calcium Hydroxide" in United States?
ABBOTT holds the US marketing authorisation.