FDA — authorised 29 July 1981
- Application: NDA018310
- Marketing authorisation holder: COVIDIEN
- Local brand name: LYMPHAZURIN
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Lymphazurin in United States
FDA authorised Lymphazurin on 29 July 1981
Marketing authorisations
FDA — authorised 29 July 1981
- Status: approved
FDA — authorised 20 July 2010
- Application: ANDA090874
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: ISOSULFAN BLUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 2 February 2016
- Application: ANDA206831
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ISOSULFAN BLUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 16 January 2019
- Application: ANDA210714
- Marketing authorisation holder: SABA ILAY SANAYI
- Local brand name: ISOSULFAN BLUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 12 July 2019
- Application: ANDA210558
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 3 November 2021
- Application: ANDA213130
- Marketing authorisation holder: MEITHEAL
- Local brand name: ISOSULFAN BLUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 16 September 2022
- Application: ANDA216090
- Marketing authorisation holder: MSN
- Local brand name: ISOSULFAN BLUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 17 May 2023
- Application: ANDA210294
- Marketing authorisation holder: AM REGENT
- Local brand name: ISOSULFAN BLUE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Lymphazurin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Lymphazurin approved in United States?
Yes. FDA authorised it on 29 July 1981; FDA authorised it on 29 July 1981; FDA authorised it on 20 July 2010.
Who is the marketing authorisation holder for Lymphazurin in United States?
COVIDIEN holds the US marketing authorisation.