FDA — authorised 17 October 2005
- Application: NDA021135
- Marketing authorisation holder: AM REGENT
- Indication: Efficacy
- Status: approved
🇺🇸 SUCROSE in United States
FDA authorised SUCROSE on 17 October 2005
Marketing authorisations
FDA — authorised 31 March 2011
- Application: ANDA078215
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
The FDA approved SUCROSE for labeling by HIKMA on September 9, 2025. This approval was granted through the standard expedited pathway. The marketing authorization holder is HIKMA, and the local brand name is not reported.
FDA — authorised 8 August 2025
- Application: ANDA212559
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA208977
- Marketing authorisation holder: INTL MEDICATION SYS
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA212340
- Marketing authorisation holder: SANDOZ
- Status: approved
SUCROSE 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 SUCROSE approved in United States?
Yes. FDA authorised it on 17 October 2005; FDA authorised it on 31 March 2011; FDA authorised it on 8 August 2025.
Who is the marketing authorisation holder for SUCROSE in United States?
AM REGENT holds the US marketing authorisation.